Auto-injector apparatus and methods for sealing a vascular puncture

ABSTRACT

Apparatus for sealing a puncture communicating with a blood vessel includes a pair of syringe barrels having sealing components therein, and a plunger assembly biased to slide within the barrels from proximal to distal positions for injecting the components through outlets of the barrels. An auto-injector assembly is coupled to the plunger apparatus, and includes a spring mechanism locked in an inactive condition and an actuator activatable to release the spring mechanism, whereupon the spring mechanism automatically advances the plunger assembly towards the distal position to inject the components from the barrels. A valve coupled to the outlets and movable from a first position for mixing and/or reconstituting the sealing components from vials, a second position where the outlets communicate with a delivery line for delivering the sealing components into a puncture, and a third position for closing the outlets.

RELATED APPLICATION DATA

[0001] This application is a continuation-in-part of application Ser.No. 10/454,362, filed Jun. 4, 2003, the disclosure of which is expresslyincorporated herein by reference.

FIELD OF INVENTION

[0002] The present invention relates generally to apparatus and methodsfor sealing punctures through tissue and, more particularly, toapparatus and methods for sealing a vascular puncture extending throughtissue into a blood vessel, and to apparatus and methods for deliveringa sealing compound into a percutaneous puncture extending from apatient's skin to a blood vessel or other body lumen to seal thepuncture.

BACKGROUND

[0003] Apparatus and methods are known for accessing a patient'svasculature percutaneously to perform a procedure within thevasculature, and for sealing the puncture that results after completingthe procedure. For example, a hollow needle may be inserted through apatient's skin and overlying tissue into a blood vessel. A guide wiremay be passed through the needle lumen into the blood vessel, whereuponthe needle may be removed. An introducer sheath may then be advancedover the guide wire into the vessel, e.g., in conjunction with orsubsequent to one or more dilators. A catheter or other device may beadvanced through the introducer sheath and over the guide wire into aposition for performing a medical procedure. In this manner, theintroducer sheath may facilitate introducing various instruments intothe vessel, while minimizing trauma to the vessel wall and/or minimizingblood loss. Upon completing the procedure, the instrument(s) andintroducer sheath may be removed, leaving a puncture extending betweenthe skin and the vessel.

[0004] To seal the puncture, external pressure may be applied to theoverlying tissue, e.g., manually and/or using sandbags, until hemostasisoccurs. This procedure, however, may be time consuming and expensive,requiring as much as an hour of a medical professional's time. It isalso uncomfortable for the patient, and may require the patient toremain immobilized in an operating room, catheter lab, or holding area.In addition, a risk of hematoma exists from bleeding before hemostasisoccurs.

[0005] Various apparatus and methods have been suggested for sealing apercutaneous puncture instead of using external pressure. For example,U.S. Pat. No. 5,108,421 to Fowler discloses a collagen plug that may bedelivered into a puncture through tissue. In one embodiment, a catheteris inserted through the puncture into the blood vessel. A balloon on thecatheter is expanded and retracted until the balloon is disposedadjacent the puncture at the wall of the vessel. The plug may beadvanced into the puncture until the plug contacts the balloon, therebypreventing the plug from entering the vessel. Once the plug ispositioned within the puncture, the balloon may be deflated andwithdrawn, leaving the plug therein to expand and seal the punctureand/or to promote hemostasis.

[0006] By way of another example, U.S. Pat. Nos. 5,192,302 and 5,222,974issued to Kensey et al. describe a biodegradable collagen plug that maybe delivered through an introducer sheath into a puncture site. Thedisclosed plug, however, may be difficult to position properly withrespect to the vessel, which may be significant since it is generallyundesirable to expose the collagen material within the bloodstream whereit may float downstream and cause an embolism.

SUMMARY OF THE INVENTION

[0007] The present invention is generally directed to apparatus andmethods for sealing a puncture in a body, including without limitation,apparatus and methods for providing temporary or permanent hemostasiswithin a vascular puncture extending into a blood vessel, and/or toapparatus and methods for delivering a sealing compound into apercutaneous puncture extending from a patient's skin to a blood vesselor other body lumen.

[0008] In one embodiment, an apparatus is provided for sealing apuncture through tissue that includes an introducer sheath, deliverysheath, or other tubular member, an occlusion member, and a retractionassembly. The tubular member may include a proximal end, a distal endhaving a size for insertion into the puncture, and a lumen extendingbetween the proximal and distal ends. The occlusion member may beslidably disposed within the tubular member and may include a proximalend, a distal end extending distally through an opening in the distalend of the tubular member, and an expandable member on the distal end.

[0009] The retraction assembly may be coupled to the tubular member andthe occlusion member for controlling axial movement of the tubularmember relative to the occlusion member. The retraction assembly mayinclude a lock for securing the tubular member in a distal positionrelative to the occlusion member, and a release or trigger fordisengaging the lock, the retraction assembly being biased to retractthe tubular member proximally relative to the occlusion member when thelock is disengaged.

[0010] The apparatus may also include a delivery device communicatingwith the proximal end of the tubular member. The delivery device mayinclude one or more plungers that are advanceable to deliver sealingcompound into the lumen, the plunger(s) configured for triggering therelease when the plunger(s) is(are) advanced to deliver the liquidsealing compound.

[0011] In another embodiment, a method is provided for sealing apuncture communicating with a body lumen using an apparatus thatincludes an occlusion member including an expandable member on a distalend thereof, an introducer sheath, delivery sheath, or other tubularmember, and a retraction assembly coupled to the occlusion member. Thetubular member may be introduced into the puncture, e.g., a percutaneouspuncture communicating with a blood vessel or other body lumen. Theocclusion member may be introduced through the tubular member into thepuncture with the expandable member in a collapsed state until theexpandable member is disposed within the body lumen.

[0012] The tubular member may be coupled to the retraction assembly,e.g., by connecting a sheath or shaft extending from the retractionassembly to a proximal end of the tubular member. The expandable membermay be expanded, and the occlusion member may be at least partiallywithdrawn from the puncture until the expandable member substantiallyseals the puncture from the body lumen.

[0013] A sealing compound may be introduced through the tubular memberinto the puncture until the retraction assembly is triggered whereuponthe tubular member may be automatically withdrawn at least partiallyfrom the puncture, thereby delivering the sealing compound along thepuncture. The sealing compound may be delivered from one or moresyringes into the tubular member when a plunger assembly of thesyringe(s) is depressed. The plunger assembly may include a trigger forreleasing a lock member of the retraction assembly when the plungerassembly is depressed a predetermined distance. Where the tubular memberis coupled to the retraction assembly by connecting a sheath or shaftextending from the retraction assembly, the sheath or shaft may bebiased to move proximally when the lock member of the retractionassembly is released, thereby withdrawing the tubular member at leastpartially from the puncture, e.g., as the sealing compound is delivered.

[0014] Thereafter, the expandable member may be collapsed, and theocclusion member may be withdrawn from the puncture. The sealingcompound may include a liquid sealing compound, and the occlusion membermay be removed from the puncture after the liquid sealing compound hasat least partially solidified.

[0015] In yet another embodiment, a method is provided for sealing apuncture communicating with a body lumen using an apparatus thatincludes an occlusion member including an expandable member on a distalend thereof, a delivery sheath, introducer sheath, or other tubularmember sheath slidable along the occlusion member, and a retractionassembly coupled to the occlusion member and the tubular member. Thetubular member and the occlusion member may be introduced into thepuncture, e.g., simultaneously or sequentially.

[0016] For example, the occlusion member may be disposed within thetubular member such that the occlusion member is introduced into thepuncture when the tubular member is introduced into the puncture.Alternatively, the occlusion member may be introduced into the puncturethrough the tubular member after the tubular member is introduced intothe puncture.

[0017] If the occlusion member is introduced after the tubular member,the tubular member may be coupled to the retraction assembly after theocclusion member is introduced into the puncture through the tubularmember. For example, a sheath may overlie a portion of the occlusionmember that may be coupled to the proximal end of the tubular memberAlternatively, if the occlusion member and tubular member are introducedsimultaneously, the tubular member may be coupled to the retractionassembly before introduction.

[0018] For example, the occlusion member may be introduced into thepuncture with the expandable member in a collapsed state until theexpandable member is disposed within the body lumen beyond the distalend of the tubular member. The expandable member is then expanded, andthe occlusion member is at least partially withdrawn from the punctureuntil the expandable member substantially seals the puncture from thebody lumen.

[0019] A sealing compound may be introduced through the tubular memberinto the puncture until the retraction assembly is triggered whereuponthe tubular member may be automatically withdrawn at least partiallyfrom the puncture, thereby delivering the sealing compound along thepuncture.

[0020] In still another embodiment, an apparatus is provided fordelivering a sealing compound into a puncture extending through tissuethat includes one or more barrels, e.g., a pair of barrels, a plungerassembly, and an auto-injection assembly. Each barrel includes a chamberfor storing a component of the sealing compound, and an access portcommunicating with the chamber. A plunger assembly including a pistonslidable within each barrel chamber from a proximal position to a distalposition for delivering the components out of the barrel chambersthrough the respective ports.

[0021] An auto-injection assembly is coupled to the plunger assemblythat includes a spring mechanism that is locked in an inactivecondition, and an actuator coupled to the spring mechanism. When thespring mechanism is inactive, the plunger assembly may be manipulatedmanually, e.g., to load sealing components into the barrels. When theactuator is activated, the spring mechanism is released, whereupon thespring mechanism may direct the pistons of the plunger assembly towardstheir distal positions to deliver the components out of the barrelchambers.

[0022] Optionally, the apparatus may include a valve coupled to thebarrel ports for selectively placing the barrel chambers incommunication with one or more inlet lines and one or more outlet lines.For example, the valve may be movable to a first or loading position inwhich the barrel chambers are in communication with the inlet line,e.g., to deliver further components from a container or other source,e.g., for mixing the sealing components in the barrel chambers with thefurther sealing components and/or for loading sealing components intothe barrels. The valve may also be movable to a second or deliveryposition wherein the barrel ports communicate with a “Y” fitting, mixer,and/or tubing, e.g., for mixing together the sealing components injectedfrom the barrels and/or delivering the sealing components into apuncture. Optionally, the valve may also be moved to a third or closedposition wherein the barrel ports are isolated to prevent the sealingcomponents from escaping.

[0023] In yet another embodiment, a method is provided for delivering asealing compound from a delivery device that includes a plurality ofbarrels and a plunger assembly including pistons slidable within thebarrels between first and second positions.

[0024] Sealing components may be provided in the barrels with theplunger assembly in the first position. For example, a valve coupled tothe barrels may be moved to a first position wherein the barrelscommunicate with a container or other source of further sealingcomponents. The plunger assembly may be manually advanced into thebarrels-to deliver the sealing components in the barrels into thecontainers to mix the sealing components with the further sealingcomponents. For example, the barrels may include one or more buffersolutions, and the containers may include powdered or other solid formsof polymer precursor compounds. Once the components are mixed, e.g., byshaking the containers, the plunger assembly may be manually withdrawnfrom the barrels to draw mixed sealing components from the containersinto the barrels.

[0025] When it is desired to deliver the sealing compound, an actuatorcoupled to a spring mechanism may be activated, whereupon the springmechanism may direct the plunger assembly to move towards the secondposition to deliver the sealing components out of the barrels. Forexample, a valve coupled to the barrel ports may be moved to a deliveryposition, wherein the ports communicate with an introducer sheath,delivery sheath, or other tubular member placed within a puncture. Whenthe actuator is activated, the sealing compounds may be deliveredthrough the tubular member and into the puncture, e.g., via anintroducer, delivery sheath, or other tubular member optionally, thesealing components in the barrels may mix in a “Y” fitting, a mixer,and/or within the tubular member itself before being delivered into thepuncture.

[0026] In still another embodiment, an occlusion apparatus is providedfor sealing a puncture extending from a patient's skin through tissue toa body lumen, e.g., for temporary hemostasis. The apparatus may includean outer member including a proximal end, a distal end having a size andshape for insertion into a puncture, and a lumen extending between theproximal and distal ends, thereby defining a longitudinal axistherebetween. An inner member may be slidably disposed within the lumenof the outer member that also includes proximal and distal ends.

[0027] The apparatus may include an expandable member that includes aproximal end coupled to the distal end of the outer member and a distalend coupled to the distal end of the inner member. In one embodiment, aninterior of the expandable member may communicate with the lumen of theouter member, the expandable member being expandable when fluid isintroduced into the interior. In another embodiment, the expandablemember may include a frame that expands when the inner member isdirected proximally relative to the outer member.

[0028] The apparatus may include a housing on the proximal end of theouter member that includes a piston slidably disposed within a chamberand coupled to the inner member, and a reservoir filled with inflationmedia communicating with the chamber. The housing includes an actuator,e.g., a depression switch coupled to another piston, that may beactivated by a user to direct the inflation media from the reservoirinto the chamber.

[0029] If the expandable member is inflatable, the reservoir and/orchamber communicate with the lumen of the outer member, and consequentlywith the interior of the expandable member. When the actuator isactivated, the expandable member is expanded substantiallysimultaneously with the piston being directed proximally to pull theinner member proximally and shorten the expandable member as it expands.If the expandable member includes an expandable frame, when the actuatoris activated, the piston pulls the inner member proximally, causing theframe to buckle and/or otherwise expand, thereby extending a membranethereon substantially transversely. The actuator may be deactivated towithdraw the inflation media from the chamber and/or the lumen into thereservoir, thereby substantially directing the piston distally to pushthe inner member distally and collapsing the expandable member.

[0030] In yet another embodiment, an apparatus is provided for sealing apuncture extending from a patient's skin to a body lumen. The apparatusmay include a tensioner and an elongate occlusion member. The occlusionmember may include a proximal end, a distal end insertable into thepuncture, and an expandable member on the distal end of the occlusionmember that may be disposed within the body lumen while the proximal endremains outside the puncture. The tensioner may include an elongate bodywith a foot on a first end thereof and a saddle on a second end thereof,the foot having a shape for placement against the patient's skinadjacent the puncture. The saddle may be moveable along or otherwiserelative to the shaft towards the foot and biased to move away from thefoot. Cooperating connectors may be provided on the foot and theproximal end of the occlusion member for securing the occlusion memberto the saddle.

[0031] During use, a distal end of the occlusion member may beintroduced into the puncture with an expandable member thereon in acollapsed state until the expandable member is disposed within the bodylumen, whereupon the expandable member may be expanded to an expandedstate within the body lumen. A foot of the tensioner may be placedagainst the patient's skin adjacent the puncture, and the saddle may bedirected towards the foot to reduce a distance between the saddle andthe foot. The saddle may be connected to a proximal end of the occlusionmember, whereupon the saddle may be released to automatically (e.g.,using spring-activated forces) move away from the foot. Thus, a proximalforce may be applied to the occlusion member to hold the expandablemember against a wall of the body lumen and substantially seal thepuncture from the body lumen, e.g., to provide temporary hemostasisbefore and/or during injection of sealing compounds into the puncture.

[0032] Other embodiments, aspects, and features of the present inventionwill become apparent from consideration of the following descriptiontaken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The figures illustrate the design and utility of exemplaryembodiments of the invention, which are shown for purposes ofillustration and not limitation, in which:

[0034]FIG. 1 is a perspective view of an apparatus for sealing apuncture through tissue including an introducer sheath, an occlusionmember, a retraction assembly, and a source of liquid sealing compound.

[0035]FIGS. 2A and 2B are perspective views of the introducer sheath andocclusion member of FIG. 1, showing a balloon on the occlusion member incollapsed and expanded states, respectively.

[0036]FIGS. 3A and 3B are cross-sectional details of a distal portion ofthe occlusion member shown in FIGS. 2A and 2B, respectively.

[0037]FIG. 4 is a side view of a hub subassembly shown on a proximal endof the occlusion member of FIGS. 2A and 2B.

[0038]FIG. 5 is a cross-sectional side view of the proximal hubsubassembly of FIG. 4, including a piston and spring therein andconnected to inner and outer members of the occlusion member.

[0039]FIG. 6 is a perspective detail, showing a piston being attached toan inner member and received in a housing to provide the proximal hubsubassembly shown in FIGS. 4 and 5.

[0040]FIGS. 7A-7C are perspective views of an expandable frame that maybe provided on an occlusion member.

[0041]FIG. 8A is a perspective view of a switch for expanding andcollapsing the expandable frame of FIGS. 7A-7C.

[0042]FIG. 8B is a detail of a pin-slot arrangement of the switch ofFIG. 8A.

[0043]FIG. 9 is a cross-sectional view of the occlusion member, theintroducer sheath assembly, and the retraction assembly of FIG. 1.

[0044]FIGS. 10A and 10B are cross-sectional details of a lock mechanismof the retraction assembly of FIG. 1 in outward locked and inwardactuated positions, respectively.

[0045]FIGS. 11A-11F are cross-sectional views of a percutaneous puncturecommunicating with a blood vessel showing a method for sealing thepuncture, in accordance with the present invention.

[0046]FIG. 12A is a perspective view of an alternative embodiment of anocclusion member, including an actuator switch for expanding and/orcollapsing a balloon thereon.

[0047]FIG. 12B is a cross-sectional view of the occlusion memberactuator switch of FIG. 12A.

[0048]FIG. 12C is an exploded perspective view of the occlusion memberof FIG. 12A.

[0049]FIG. 13 is a cross-sectional view of a tensioner for supportingthe occlusion member of FIGS. 12A and 12B.

[0050]FIGS. 14A and 14B are perspective views, showing the occlusionmember of FIGS. 12A and 12B being coupled to the tensioner of FIG. 13.

[0051]FIG. 15 is a perspective view of a linear valve.

[0052]FIG. 16A is a front view of a syringe assembly connected to alinear valve, such as that shown in FIG. 15, with the valve in a firstposition connecting the syringe assembly to vials or precursor polymercompounds.

[0053]FIG. 16B is a side view of the syringe assembly of FIG. 16A, withthe linear valve in a second position connecting the syringe assembly toa “Y” fitting.

[0054]FIGS. 17A-17C are end views of a revolver valve that may beconnected to a syringe assembly, rotated into three different positions.

[0055]FIG. 18A is a perspective view of another embodiment of anapparatus for sealing a puncture through tissue, including a retractionassembly, an introducer sheath, and an occlusion member.

[0056]FIGS. 18B and 18C are cross-sectional details of the apparatus ofFIG. 18A.

[0057]FIG. 19A is a perspective view of an auto-injector device fordelivering a sealing compound.

[0058]FIG. 19B is a cross-section of the auto-injector device of FIG.19A, taken along line 19B-19B.

[0059]FIG. 19C is an exploded perspective view of the auto-injectordevice of FIG. 19A.

[0060]FIGS. 20A-20F are cross-sectional views of another embodiment ofan auto-injector device, including internal springs.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0061]FIGS. 1-6 depict an exemplary embodiment of an apparatus 2 forsealing a puncture extending through tissue and/or communicating with abody lumen (not shown). Generally, the apparatus 2 includes an occlusionmember 4 carrying a balloon 80 or other expandable member, an introducersheath assembly 6 slidable relative to the occlusion member 4, adelivery device 8 for delivering sealing material through the introducersheath assembly 6, and a retraction assembly 10 for controlling movementof the introducer sheath assembly 6 relative to the occlusion member 4.

[0062] Turning to FIGS. 1, 2A, and 2B, the introducer sheath assembly 6generally includes an outer sleeve or introducer sheath 90 including aproximal end 92, a distal end 94, and a housing 98 on the proximal end92 defining a cavity 99. The introducer sheath 90 may be an elongatetubular member including a lumen 96 (not shown, see FIGS. 11A-11E) thatextends between the proximal and distal ends 92, 94. Preferably, theintroducer sheath 90 terminates in a tapered distal tip 95 forfacilitating advancing the introducer sheath 90 through a puncture.Exemplary materials for the introducer sheath 90 may include plastics,such as polyamide, PEEK, nylon, PET, PEBAX, and polyethylene, metals,such as stainless steel, and nickel titanium, and/or compositematerials.

[0063] The housing 98 may include a generally annular body 100 attachedor otherwise coupled to the proximal end 92 of the introducer sheath 90.The housing 98 may include one or more side ports 102 that communicatewith the cavity 99 and the lumen 96 of the introducer sheath 90. Asingle side port 102 is provided that may include a luer lock or otherconnector, e.g., to facilitate connecting tubing 106 and the like to theside port 102. In addition, the housing 98 may include a flange 104 orother connector (not shown) that may be used to couple the introducersheath assembly 6 to the retraction assembly 8, as described furtherbelow. Alternatively, the introducer sheath 90 may be a conventionalintroducer sheath, such as those well known in the art.

[0064] The introducer sheath assembly 6 is configured for slidablyreceiving the occlusion member 4 therein, as described further below.For example, the occlusion member 4 may be inserted through the lumen 96of the introducer sheath 90 such that the balloon 80 is disposeddistally beyond the distal end 94 of the introducer sheath 90. From thisdistal position, the introducer sheath assembly 6 may be slidableproximally relative to the occlusion member 4, e.g., to facilitatedelivering sealing material around the occlusion member 4, as shown inFIGS. 11A-11F and described further below. The occlusion member 4 andintroducer sheath assembly 6 may include cooperating detents,connectors, or other features (not shown) that may interact to limitrelative movement of the introducer sheath assembly 6 relative to theocclusion member 4. For example, the introducer sheath assembly 4 may beslidable along the occlusion member 4, and the cooperating features mayprevent the distal end 96 of the introducer sheath 90 from being movedcloser to the balloon 80 than a desired minimum distance, e.g., not morethan about five millimeters (5 mm), as explained further below.

[0065] To substantially seal the introducer sheath assembly 6 around theouter member 12 of the occlusion member 4, the housing 98 may includeone or more annular seals (not shown) that provide a fluid-tight sealaround the outer member 12 (or other instruments, not shown, insertedinto the introducer sheath assembly 6) yet allow the introducer sheathassembly 6 to slide along the outer member 12. Thus, when fluids aredelivered into the housing 98 from the side port 102, the seals 99 mayprevent the sealing compound from leaking out of the housing 98, andinstead the fluids may pass through the lumen 96 of the introducersheath 90, as described further below.

[0066] As best seen in FIGS. 2A, 2B, 3A, and 3B, the occlusion member 4is an elongate structure including an outer member 12, an inner member32 slidably coupled to the outer member 12, and a hub subassembly 38 orother mechanism for biasing the inner member 32 relative to the outermember 12. The balloon 80 or other expandable member (not shown) iscarried by the occlusion member 4, and preferably coupled to the innerand outer members 32, 12, as described more particularly below. Althoughexemplary embodiments of the occlusion member 4 are described herein,additional information on structures and operation of an occlusionmember that may be included in the apparatus 2 are disclosed inabove-incorporated application Ser. No. 10/454,362.

[0067] The outer member 12 may be an elongate tubular body including aproximal end 14, a distal end 16, and a lumen 18 extending therebetween(shown in FIGS. 3A, 3B, and 5), thereby defining a longitudinal axis 20.The outer member 12 may be flexible, semi-rigid, or rigid, e.g., havinga uniform or variable flexibility along its length. A proximal portionof the outer member 12 may be substantially rigid, e.g., a section ofhypotube (not shown), to facilitate advancing the occlusion member 4through a tubular member, such as the introducer sheath assembly 6.Optionally, a lubricious coating (not shown) may be provided on theexterior of the outer member 12.

[0068] In one embodiment, the distal end 16 is substantially flexiblesuch that the distal end 16 may curve, bend, prolapse, or otherwiseconform substantially to the contour of a puncture and/or other bodylumen (not shown) into which the distal end 16 is inserted. In otherembodiments, such as those described below, the distal end 16 mayinclude detents, seals, and/or other components (not shown) tofacilitate cooperation with the introducer sheath assembly 6. The distalend 16 of the outer member 12 may have a size sufficient to be insertedinto a relatively small puncture and/or body lumen. For example, thedistal end 16 (and possibly the remainder of the outer member 12) mayhave an outer diameter between about 0.010-0.030 inch (0.25-0.75 mm),and less than about 0.020 inch (0.5 mm) in certain embodiments.

[0069] The inner member 32 may be an elongate body including a proximalend 34 (shown in FIGS. 5 and 6), and a distal end 36. As best seen inFIGS. 3A and 3B, the inner member 32 may be slidably received within thelumen 18 of the outer member 12 such that the distal end 36 of the innermember 32 extends beyond the distal end 16 of the outer member 12.Preferably, the inner member 32 is sufficiently small such that theinner member 32 may be received in the lumen 18 of the outer member 12,yet accommodate fluid being delivered through the lumen 18, i.e., alongan exterior of the inner member 32. The inner member 32 may be a solidwire of nickel-titanium alloy (“Nitinol”), stainless steel, polymeric,and/or composite material having an outer diameter between about0.003-0.020 inch (0.075-0.5 mm), and less than about 0.010 inch (0.25mm) in certain embodiments. Alternatively, the inner member 32 mayinclude a lumen (not shown) for receiving a guidewire (not shown)therethrough, e.g., such that the occlusion member 4 may be advancedover a guidewire.

[0070] The inner member 32 may be biased to move distally relative tothe outer member 12, i.e., from a proximal position (such as that shownin FIG. 3B) to a distal position (such as that shown in FIG. 3A), e.g.,to facilitate collapsing the balloon 80. For example, as shown in FIGS.4-6, hub subassembly 38 may be provided for biasing the inner member 32relative to the outer member 12. Generally, the hub subassembly 38 mayinclude a housing 40 extending proximally from the proximal end 14 ofthe outer member 12 and a piston 60 coupled to the proximal end 34 ofthe inner member 32. As best seen in FIG. 4, the housing 40 may includea hollow adaptor end 42, a side port 44 communicating with an interior46 of the housing 40, and a hollow cylinder 48. The cylinder 48 mayinclude an outer wall 50 and a proximal end wall 52, thereby defining achamber 54 that communicates with the interior 46 of the housing 40. Theend wall 52 may only partially enclose the chamber 54 or maysubstantially seal the chamber 54, as explained further below.

[0071] The adapter end 42 of the housing 40 may be attached to theproximal end 14 of the outer member 12 such that the interior 46 of thehousing 40 communicates with the lumen 18 of the outer member 12. Forexample, the adapter end 42 may be attached to the proximal end 14 ofthe outer member 12 using an adhesive, an interference fit, matingthreads, and/or other connectors, e.g., to substantially permanentlyattach the housing 40 to the proximal end 14 of the outer member 12.With the housing 40 attached to the outer member 12, the side port 44may communicate with the lumen 18 via the interior 46 of the housing 40.Thus, fluid delivered into the side port 44 may enter the lumen 18 aswell as the chamber 54 of the cylinder 48 via the interior 46 of thehousing 40.

[0072] The side port 44 may include a connector, e.g., a luer lockconnector, or a nipple (not shown) for connecting tubing or otherwiseconnecting a source of fluid or other inflation media to the side port44. For example, a syringe filled with inflation media, e.g., saline,carbon dioxide, and the like (not shown), may be connected to the sideport 44 for manually delivering the inflation media into the lumen 18.Alternatively, a pump or other device (also not shown) may be providedfor delivering fluid at a desired pressure and/or flow rate.

[0073] As best seen in FIG. 5, the piston 60 may be slidably received inthe cylinder 48, thereby dividing the chamber 54 into a proximal chamber54 a and a distal chamber 54 b. The piston 60 may include one or moreseals 62 for providing a fluid-tight seal between the piston 60 and theside wall 50 of the cylinder 48, while accommodating the piston 60sliding within the chamber 54. The piston 50 may include a distalsurface 66 that is exposed to fluid pressure within the distal chamber54 b, and consequently to fluid pressure within the interior 46 of thehousing 40 and/or within the lumen 18 of the outer member 12.

[0074] The proximal end 34 of the inner member 32 may be coupled to thepiston 60, thereby coupling axial movement of the inner member 32 toaxial movement of the piston 60, as shown in FIG. 5. For example, asshown in FIG. 6, the distal surface 66 of the piston 50 may include anaperture 68 through which the proximal end 34 of the inner member 32 maybe received. Once the inner member 12 is inserted a desired distanceinto the aperture 68, the inner member 12 may be secured to the piston60 using known mechanisms, such as a set screw 70 and/or adhesive.

[0075] To provide a biasing force, e.g., to facilitate returning theocclusion member to a minimum profile, a compression spring or othermechanism 74 may be provided in the proximal chamber 54 a of the housing40, e.g., for biasing the piston 60 away from the end wall 52, i.e.,towards the adapter end 42 of the housing 40. The spring 74 may apply anaxial force against a proximal surface 76 of the piston 60 and the endwall 52 of the cylinder 48. The spring constant of the spring 74 may beselected to provide a desired biasing force.

[0076] In an alternative embodiment, the proximal chamber 46 a of thecylinder 48 may be filled with a compressible fluid, e.g., nitrogen,carbon dioxide, or air, that may be pressurized to a predeterminedpressure to bias the piston 50 away from the end wall 44. As fluid isintroduced into the distal chamber 46 b, the pressure of the fluid mayexceed the predetermined pressure, thereby causing the piston 60 to moveproximally and compress the fluid within the proximal chamber 46 a untilthe pressures within the chambers 46 a, 46 b are substantially equal toone another. In another alternative embodiment, an extension spring (notshown) may be provided in the distal chamber 54 b that may be coupled tothe piston 60 and the cylinder 48 at the end near the side port 44 tobias the piston 60 distally.

[0077] In yet another alternative, the hub subassembly 38 may notinclude a biasing mechanism, e.g., no spring 74 or compressible fluid.Instead, movement of the piston 60 may be controlled directly by thepressure and/or vacuum applied to inflate and/or deflate the balloon 80,respectively. For example, when a substantially incompressible fluid isdelivered into the lumen 18 of the outer member 12, the pressuredifferential between the piston 60 and the balloon 80 may initiallycause the piston 60 to slide proximally, thereby applying a proximaltensional load to the inner member 32 while the balloon 80 is expanding.When a negative pressure (vacuum) is applied to evacuate the fluid fromthe lumen 18 and deflate the balloon 80, the negative pressuredifferential between the piston 60 and the balloon 80 may initiallycause the piston 60 to slide distally, thereby applying a distalcompressive load to the inner member 32 while the balloon 80 isdeflating.

[0078] A desired pressure differential may be achieved by using aviscous fluid (i.e., a fluid more viscous than air) and/or by creating arestriction (not shown) within the lumen 18 distal to the side port 44to delay the pressure from entering or exiting the balloon 80. Thispressure differential may be particularly important when inflatingand/or deflating an everted balloon. In addition, or alternatively, aconstriction (not shown) may be provided within the lumen 18, e.g.,between the side port 44 and the distal end 16 to cause the piston 60 tomove before fluid is introduced into the balloon 80. Optionally,cooperating stops (not shown) may be provided for preventing overinflation of the balloon 80, as described in application Ser. No.10/454,362 incorporated by reference herein.

[0079] Returning to FIGS. 1-3B, the balloon 80 is carried on the distalend 16 of the outer member 12. Generally, the balloon 80 may beexpandable from a collapsed state (shown in FIGS. 2A and 3A) to anexpanded state (shown in FIGS. 2B and 3B) when a fluid or otherinflation media (not shown) is introduced into an interior 82 of theballoon 80. In an alternative embodiment, other expandable members,e.g., a mechanically expandable or self-expanding member (not shown) maybe provided instead of the balloon 80, as described further below.

[0080] The balloon 80 may be formed from a flexible, substantiallyinelastic material, e.g., a nonelastomeric material, such as PET, nylon,polyethylene, polyurethane, PEBAX, and the like, that may provide asubstantially noncompliant or semi-compliant balloon 80 that may expandto a predetermined size once a minimum pressure is introduced into theinterior 82. In this embodiment, the size of the balloon 80 in theexpanded state may be fixed. Alternatively, the balloon 80 may be formedfrom an elastic material, such that the size of the balloon 80 in theexpanded state is dependent upon the pressure or volume of fluiddelivered within the interior 82, as is known in the art.

[0081] The balloon 80 may include a proximal end 84, a distal end 86,and an expandable intermediate section 88 defining the interior 82 ofthe balloon 80. The proximal end 84 of the balloon 80 may be attached tothe distal end 16 of the outer member 12, and the distal end 86 of theballoon 80 may be attached to the distal end 36 of the inner member 32.When the proximal end 84 of the balloon 80 is attached to the outermember 12, the interior 82 of the balloon 80 may communicate with thelumen 18 of the outer member 12. Alternatively, the proximal end 84 ofthe balloon 80 may extend proximally, replacing all or a portion of theouter member 12 (not shown). In a further alternative, the proximal end84 of the balloon 80 may be laminated or drawn over a stiffer proximalshaft (not shown).

[0082] As best seen in FIGS. 3A and 3B, the proximal end 84 of theballoon 80 may overlie and be attached to the distal end 16 of the outermember 12, e.g., using an adhesive, sonic welding, crimping, aninterference fit, and the like. The distal end 36 of the inner member 32may extend through the interior 82 of the balloon 80 (i.e., through theintermediate section 88), and at least partially into the distal end 86of the balloon 80, optionally extending an entire length of the distalend 86 of the balloon 80. Similar to the proximal end 84, the distal end86 of the balloon 80 may be attached to the distal end 36 of the innermember 32, e.g., using an adhesive, sonic welding, crimping, acompressive sleeve, an interference fit, and the like.

[0083] An annular band of material, e.g., polyimide or PET, may beattached or otherwise provided over the proximal and distal ends 84, 86of the balloon 80 to attach the ends 84, 86 to the outer and innermembers 12, 32. For example, a band may be provided around the proximalend 84 of the balloon 80 to prevent the balloon 80 from delaminatingfrom the outer member 12 when the balloon 80 is inflated.

[0084] The distal end 86 of the balloon 80 may extend beyond the distalend 36 of the inner member 32, e.g., to provide a floppy or otherwisesubstantially atraumatic tip for the occlusion member 4. For example,the distal end 86 of the balloon 80 may have a length of at least aboutfifty millimeters (50 mm), and the distal end 36 of the inner member 32may only extend about twenty millimeters (20 mm) or less into the distalend 86 of the balloon 80. Alternatively, the distal end 36 of the innermember 32 may extend beyond the distal end 86 of the balloon 80, and mayterminate in a substantially atraumatic tip (not shown). The atraumatictip may mimic the behavior of a standard “J”-tip guide wire, e.g., a0.035 inch or 0.038 inch wire, commonly used with introducer sheaths.

[0085] In the collapsed state, shown in FIGS. 2A and 3A, the balloon 80may conform substantially to the diameter of the outer member 12.Preferably, the proximal and distal ends 84, 86 of the balloon 80 andthe distance between the distal ends 16, 36 of the outer and innermembers 12, 32 are such that the balloon 80 is under slight axialtension in the collapsed state, thereby minimizing risk of the balloon80 expanding, kinking, or otherwise increasing in cross-section and/orcatching on anything contacted by the balloon 80.

[0086] The balloon 80 is expanded to the expanded state, shown in FIGS.2B and 3B, by introducing inflation media (not shown) into the lumen 18of the outer member 12, and consequently into the interior 82 of theballoon 80. As explained above, when fluid is introduced into the lumen18, the fluid initially enters the interior 46 of the housing 40 (notshown, see FIGS. 4 and 5), and consequently into the distal chamber 54 bof the cylinder 48 (also not shown, see FIGS. 4 and 5). As the fluidpressure within the distal chamber 54 b exceeds the bias of the spring74 (or other biasing mechanism), the piston 60 may move proximallywithin the cylinder 48, thereby pulling the inner member 32 proximally.

[0087] As best seen in FIGS. 3A and 3B, proximal movement of the innermember 32 relative to the outer member 12 causes the distal end 86 ofthe balloon 80 to move towards the proximal end 84 of the balloon 80.Thus, in the collapsed state, the intermediate section 88 of the balloon80 may have a length L_(C), while, in the expanded state, theintermediate section 88 may have a length L_(E) that is substantiallyshorter than L_(C). In the expanded state, the balloon 80 may have adiameter between about four and ten millimeters (4-10 mm), and a lengthL_(E) between about two and ten millimeters (2-10 mm). For example, inan exemplary embodiment, the balloon may have a diameter of about sixmillimeters (6 mm) at thirty pounds per square inch (30 psi) internalpressure and a length L_(E) of about four millimeters (4 mm).

[0088] In one embodiment, the balloon 80 at least partially everts inthe expanded state, i.e., the length L_(E) of the balloon 80 may besubstantially smaller than the diameter. Stated differently, in theexpanded state, the proximal and distal ends 84, 86 of the balloon 80may become sufficiently close to one another that they at leastpartially enter the interior 82 of the balloon 80, as shown in FIG. 3B,thereby defining a toroidal shape. This everted configuration (which mayalso be referred to as a “bagel balloon” configuration) may facilitatecreating hemostasis within a puncture in a wall of a body lumen (notshown) while allowing increased fluid flow and/or vessel perfusion tocontinue along the body lumen, as explained further below.

[0089] With reference to FIGS. 3A, 3B, and 5, the cross-section of thedistal chamber 54 b of the cylinder 48 may be substantially larger thana cross-section of the lumen 18 of the outer member 12. When a fluid isintroduced into the side port 44 of the hub subassembly 38 underpressure, the pressure may impose a proximal force on the distal surface66 of the piston 60. Because of the relatively large area of the distalchamber 54 b, fluid may flow easily into the distal chamber 54 b beforeflowing down the lumen 18 into the interior of the balloon 80. Thus, asfluid is introduced into the side port 44, a proximal force may beapplied to the piston 60 before or as the balloon begins to expand,thereby shortening the balloon 80 before or as it expands towards theexpanded state. Conversely, when fluid is evacuated out of the side port44, the fluid from the distal chamber 54 b of the cylinder 48 may beremoved before fluid is drawn up the lumen 18 and the balloon 80 beginsto collapse. The resulting vacuum may pull the piston 60 distally,causing the balloon 80 to elongate towards its collapsed length L_(C)before or as the balloon collapses towards the collapsed state. Thisfeature may be particularly useful for ensuring that the balloon 80 iscollapsed to as small a profile as possible when the balloon 80 iscollapsed from the expanded state to the collapsed state, e.g., tominimize disruption of any sealing compound deposited in the puncture asthe balloon 80 is withdrawn, as explained elsewhere herein.

[0090] In alternative embodiments, other expandable members may beprovided on the distal ends 16, 36 of the outer and/or inner members 12,32. For example, instead of a single chamber balloon, as describedabove, a balloon may be provided that includes multiple chambers or“lobes” (not shown). Each lobe may be connected to the lumen 18 withinthe outer member 12 such that inflation media may enter each lobe toexpand the balloon into a desired shape. Alternatively, the occlusionmember 4 may include multiple lumens (not shown) that communicate withone or more lobes such that the lobes may be independently expanded, ifdesired. For example, the lobes may expand away from one anothertransversely relative to the longitudinal axis 20, thereby defining arelatively flat annular or “flower” configuration that may provide asubstantially fluid-tight seal, yet allow perfusion to continue along avessel, similar to the apparatus and methods described further below.

[0091] In other embodiments, mechanically expandable members may beprovided, rather than fluid-expandable members. For example, anexpandable frame (not shown) may be coupled to the distal ends 16, 36 ofthe outer and inner members 12, 32 that may be expanded as the innermember 32 is directed proximally relative to the outer member 12. Anonporous membrane may cover or otherwise be connected to the frame suchthat the membrane is expanded with the frame, thereby providing arelatively flat annular member that may be used to provided temporaryhemostasis during delivery of a sealing compound, as described furtherbelow. Exemplary frames and membranes that may be used in conjunctionwith embodiments of the invention are described in U.S. Pat. Nos.5,782,860, 5,922,009, 6,056,769, and 6,464,712, the disclosures of whichare expressly incorporated by reference herein.

[0092] For example, FIGS. 7A-7C show an exemplary embodiment of anexpandable frame 180 that may be provided on an occlusion member 4.′ InFIG. 7C, a nonporous membrane 189 coupled to the frame 180 is shown inphantom, while in FIGS. 7A and 7B, the nonporous membrane 189 is omittedfor convenience. The membrane 189 may cover all or a portion of theframe 180. For example, in one embodiment, the membrane 189 may onlycover a proximal portion of the frame 180.

[0093] As shown in FIG. 7A, the frame 180 may be created by forming aplurality of longitudinal slits 182 in a tube, e.g., a Nitinol tube,using known procedures, such as laser cutting, to create struts 184therebetween. Ends 186, 188 of the frame 180 may be coupled torespective distal ends 16,′ 36′ of the outer and inner outer members12,′ 32,′ similar to the ends of the balloon 80 described above.

[0094] As shown in FIGS. 7B and 7C, as the inner member 32′ is directedproximally relative to the outer member 12,′ the struts 184 created bythe slits 182 may buckle and expand transversely, to expand the membrane189. Preferably, the slits 182 are formed to facilitate buckling of thestruts 184. For example, as shown in FIG. 7A, an intermediate portion182 a of the slits 182 may be widened to provide a weak point 184 a atwhich the struts 184 may buckle. Alternatively or in addition, the slits182 may be curved at the intermediate portion 182 a, e.g., defining aportion of a sinusoidal wave (not shown), to further control buckling ofthe struts 184, and/or to provide strain relief. The frame 180 andmembrane 184 may be collapsed again by directing the inner member 32′distally relative to the outer member 12.′ To expand and/or collapse theframe 182, an actuator may be provided on the occlusion member 4.′ Forexample, similar to the hub subassembly 38 described with respect to theballoon 80, a piston-cylinder arrangement may be provided on theproximal end 14′ of the outer member 12′ to direct the inner member 32′proximally and/or distally when a fluid is directed into the cylinder.In this embodiment, there would be no need for the fluid to flow downthe lumen of the outer member 12′ since expansion of the expandableframe 180 depends only upon the relative positions of the outer andinner members 12,′ 32.′ Alternatively, a mechanical switch 38′ may beprovided, such as that shown in FIGS. 8A and 8B. An outer housing 40′may be coupled to the proximal end 14′ of the outer member 12,′ and apiston 60′ coupled to the inner member 32′ and slidably disposed withinthe housing 40.′ A pin 61′ may be coupled to the piston 60′ that extendsthrough a “C” or “S” shaped slot 41′ in the housing 40.′ As shown inFIG. 8B, horizontal portions of the slot 41′ may correspond to theproximal and distal positions in which the frame 182 (not shown, seeFIGS. 7A-7C) is expanded and collapsed, respectively. The pin 61′ may beslid horizontally out of one of the proximal and distal positions andmoved along the slot 41′ to the other position. Optionally, a spring orother mechanism may be provided for biasing the piston 60′ distally orproximally, e.g., an extension spring 74′ may be provided for biasingthe frame 180 towards the collapsed state, similar to thefluid-activated mechanism described above.

[0095] In another alternative, the expandable frame may be biased to theexpanded state, and a cover, e.g., a catheter, sheath, sleeve, and thelike (not shown), may be provided for constraining the expandable framein the collapsed state. For example, the struts of the expandable framemay be provided from a shape memory and/or superelastic material, e.g.,Nitinol, that may be heat treated to the expanded state. The cover mayextend along the outer member of the occlusion member, e.g., from theexpandable frame towards the proximal end of the occlusion member.

[0096] Initially, e.g., during manufacturing and/or set-up, the covermay be directed over the expandable frame to resiliently force thestruts to collapse towards the collapsed state. In the collapsed state,the occlusion member may be inserted into a puncture, e.g., through adelivery sheath or other tubular member, as described elsewhere herein.When it is desired to deploy the expandable frame, the cover may be atleast partially retracted to expose the expandable frame, whereupon thestruts may automatically expand towards the expanded state.

[0097] When it is desired to remove the occlusion member, the cover maybe advanced back over the expandable frame to collapse the struts.Alternatively, the struts may be sufficiently resilient that theocclusion member may be removed without covering the expandable framesuch that the struts contact the delivery sheath and collapse as theyare drawn into the delivery sheath as the occlusion member is withdrawn.

[0098] Turning to FIGS. 12A-12C, another embodiment of an occlusionmember 204 is shown. Similar to the previous embodiments, the occlusionmember 204 includes an outer member 212, an inner member 232 slidablycoupled to the outer member 212, a hub subassembly 238 (shown in FIG.12B) for biasing the inner member 232 relative to the outer member 212,and a balloon or other expandable member 280 (shown expanded in FIGS.12A and 12C) coupled to the inner and outer members 232, 212. Unlike theprevious embodiments, the hub subassembly 238 is self-contained, ratherthan requiring a syringe or other source of inflation media forexpanding the balloon 280, e.g., to improve ease of use and/or allowsingle user operability.

[0099] The outer member 212 may be an elongate tubular body including aproximal end 214, a distal end 2-16, and a lumen 218 extending betweenthe proximal and distal ends 214, 216, thereby defining a longitudinalaxis 220. The inner member 232 may be an elongate wire or other bodyincluding a proximal end 234 and a distal end 236. As best seen in FIG.12B, the inner member 232 is slidably received within the lumen 218 ofthe outer member 212 such that the distal end 236 of the inner member232 extends beyond the distal end 216 of the outer member 212. Theballoon 280 is coupled to the distal ends 216, 236 of the outer andinner members 212, 232 such that an interior of the balloon 280communicates with the lumen 218 of the outer member 212, similar to theembodiments described above.

[0100] Preferably, the inner member 232 is biased to move distallyrelative to the outer member 212, i.e., from a proximal position to adistal position (similar to the arrangement shown in FIGS. 3A and 3B,e.g., to facilitate collapsing the balloon 280). For example, the hubsubassembly 238 may bias the inner member 232 relative to the outermember 212, similar to the previous embodiments. Generally, as shown inFIG. 12B, the hub subassembly 238 includes a housing 240 extendingproximally from the proximal end 214 of the outer member 212 and apiston 243 coupled to the proximal end 234 of the inner member 232. Inone embodiment, the piston 243 is biased distally within a chamber 242of the housing 240 by a spring 274.

[0101] The housing 240 also includes an actuator, such as a depressionswitch 248, and a passage 244 connecting the chamber 242 with areservoir 246. The switch 248 may include a handle or button 248 a and apiston 248 b extending from the handle 248 a into the reservoir 246. Thereservoir 246 may be filled with fluid, thereby allowing fluid to flowinto and out of the chamber 242 and the lumen 218 of the outer member212. For example, the reservoir 246 may be filled via valve 247 from asyringe or other source of inflation media (not shown), similar to theembodiments described above, to cause the balloon 280 to expand andcollapse when the switch 247 is activated and deactivated, respectively.Preferably, the reservoir 246 is filled sufficiently with the piston 243in its distal position and the balloon 280 collapsed without causing thepiston 243 to move distally and/or the balloon 280 to expand.

[0102] Thereafter, during use, when it is desired to expand the balloon280, the switch 248 may be depressed to direct the piston 248 b into thereservoir 246 to force fluid from the reservoir 246 into the chamber 242and lumen 218, thereby directing the piston 243 proximally as theballoon 280 expands, similar to the previous embodiments. In a preferredembodiment, the switch 248 is a depression switch that may be depresseddistally to expand the balloon 280. When the switch 248 is depressedagain, a spring 249 coupled to the switch 248, e.g., surrounding thepiston 248 a, may direct the switch 248 proximally to its originalposition, thereby drawing fluid back into the reservoir 246 from thechamber 242 and lumen 218, and collapsing and extending the balloon 280as the piston 243 moves distally.

[0103] Alternatively, other switches, e.g., rotation switches and thelike (not shown), may be provided instead of the depression switch 248.In addition or alternatively, other piston/spring arrangements may beprovided in the housing 240, similar to the previous embodiments.

[0104] In addition, the occlusion member 204 may include a cover 239 forconcealing and/or protecting the internal components of the housing 240,actuator, etc. As described more particularly below, the cover 239 mayinclude sets of grooves for connecting the occlusion member 204 to atensioner, such as that shown in FIG. 13. Optionally, a window 245 maybe provided in the cover 239 for observing the piston 243 within thehousing 240. For example, the window or cover may include graduatedmarkings (not shown) indicating a pressure level, and the piston 243 mayinclude a visual marker (also not shown). As the piston 243 slideswithin the housing 240, the visual marker on the piston 243 may alignwith the graduated markings along the window 245, thereby indicating thepressure within the housing 240. This may facilitate initially fillingthe reservoir 246 during set-up. In addition or alternatively, if aswitch having multiple positions is provided, the graduated markings mayindicate the position of the piston and the internal pressure as theswitch is ratcheted through the multiple positions.

[0105] Returning again to FIG. 1, the delivery device 8 may include adual syringe assembly 130 that includes two components of a sealingcompound, a “Y” fitting 140, and a static mixer 110. The syringeassembly 130 may include a pair of syringe barrels 132 including accessports or outlets 136 and a plunger assembly 133 slidable into thebarrels 132 to cause the components therein to be delivered through theoutlets 136. In one embodiment, the plunger assembly 133 includes a pairof plungers 134 that are coupled to one another yet are received inrespective barrels 132. Thus, both plungers 134 may be manuallydepressed substantially simultaneously to deliver the components in thesyringe barrels 132 out together.

[0106] The plunger assembly 133 may also include a trigger that mayactuate the retraction assembly 10, as described further below. Forexample, as shown in FIG. 1, the trigger may be a shaft or piston 135that extends distally between the plungers 134. Thus, when the plungers134 are inserted into the barrels 132, the shaft 135 may extend distallybetween the barrels 132.

[0107] The “Y” fitting 140 may include proximal sections 142 thatcommunicate with a single distal section 144. Thus, the “Y” fitting 140may be connectable to outlets 136 of the syringes 132 such that thecomponents ejected out of the syringes 132 may mix before beingdelivered into the side port 102 of the introducer sheath assembly 6.The proximal and distal sections 142, 144 may include connectors, e.g.,luer lock connectors and the like (not shown), for connecting withoutlets 136 of the syringes 132 and/or with the mixer 110, the tubing106, and/or the side port 102 of the introducer sheath assembly 6. The“Y” fitting 140 may have a variety of shapes, depending upon theperformances properties and/or manufacturing parameters, and should notbe restricted to a particular shape, such as a true “Y” shape, but maystill be referred to as a “Y” fitting.

[0108] The mixer 110 may be a tubular body including vanes or otherinternal structures (not shown) that enhance the components mixingthoroughly together as they pass therethrough. Similar to the “Y”fitting 140, the mixer 110 may include connectors (not shown) forreleasably or substantially permanently connecting the mixer 110 to the“Y” fitting 140, tubing 106, and the like.

[0109] In one embodiment, a liquid precursor polymer compound isprovided in each syringe barrel 132 of the syringe assembly 130 that,when mixed together, may be activated to form a hydrogel. Additionalinformation on hydrogels and systems for delivering them are disclosedin U.S. Pat. Nos. 6,152,943, 6,165,201, 6,179,862, 6,514,534, and6,379,373, and in co-pending applications Ser. Nos. 09/776,120 filedFeb. 2, 2001, 10/010,715 filed Nov. 9, 2001, and 10/068,807 filed Feb.5, 2002. The disclosures of these references and any others citedtherein are expressly incorporated by reference herein.

[0110] Optionally, the syringe assembly 130 may include one or morevalves coupled to the outlets 136 of the syringes 132. For example, avalve may be used to connect the syringe barrels 132 to a source ofsealing components for introducing the components into the syringebarrels 132 during set-up before sealing a puncture created during aprocedure. Once the syringe barrels 132 are loaded, the valve may beclosed to substantially seal the outlets 136, e.g., to temporarily storethe components during a procedure. Finally, the valve may be used toconnect the syringes 132 to the “Y” fitting 140 or other delivery lineto allow the components to be delivered into a puncture.

[0111] As shown in FIGS. 15, 16A, and 16B, an embodiment of a linearvalve 310 is shown that may be incorporated into a delivery device 308.As best seen in FIG. 15, the valve 310 generally includes a piston orother member 314 slidable within a housing 312. The housing 312 includestwo sets of side ports 316 a, 316 b that may be aligned with lumens 318extending through the piston 314 when the piston 314 is in first andsecond positions, respectively. The lumens 318 may be coupled to theoutlets of respective syringe barrels of a syringe assembly (not shown)at end ports 320.

[0112] As best seen in FIGS. 16A and 16B, the linear valve 310 may becoupled to the delivery device 308, e.g., by tubing 324. For example,outlets 336 of syringe barrels 332 may be coupled to the end ports 320(shown in FIG. 15) by tubing 324 c. The first set of side ports 316 amay be connected to a source of sealing components, such as vials 322(not shown), by tubing 324 a. The second set of ports 316 b may becoupled to inlets 432 of a “Y” fitting 339 by tubing 324 b.

[0113] During use, the valve 310 may be placed in the first positionshown in FIG. 16A, e.g., by directing actuator button 350 proximally.Sealing compound, e.g., precursor polymer components, may then beloaded, mixed, and/or reconstituted from the vials 322 into respectivesyringe barrels 332 via the tubing 324 a, side ports 316 a, lumens 318,end ports 320, and tubing 324c. For example, in one embodiment, thesyringe barrels 332 may include liquid solvent and/or buffer solution,and the vials 322 may include precursor polymer components in powder orother solid form. With the valve in the first position, the plungerassembly 333 may be depressed, delivering the liquid buffer solutionthrough the valve 310 into the vials 322.

[0114] The valve 310 may then be moved to a closed position, e.g., anintermediate position such that the lumens 318 do not communicate witheither of the sets of side-ports 316 a, 316 b. The vials 322 (e.g.,along with the entire delivery device 308) may then be shaken to mixand/or reconstitute the precursor polymer compounds into liquid form.The valve 310 may then be returned to the first position, and theplunger assembly 133 may be withdrawn from the syringe barrels 332 inorder to draw a desired amount of the reconstituted precursor componentsinto the barrels 332. For example, the barrels 332 may be loaded onlywith a predetermined amount of the components based upon anapproximation of the volume to be delivered into a puncture beingsealed. The barrels 332 may include volumetric graduation indicatorsthat may guide a user to draw the predetermined amount of sealingcomponents into the barrels 332.

[0115] When it is time to deliver the sealing components, the valve 310may be placed in the second position shown in FIG. 16B, e.g., bydirecting the actuator button 350 distally. In this position, theoutlets 336 of the syringes 332 communicate with the “Y” fitting 340,allowing the sealing compound to be delivered via the tubing 324 c, endports 320, lumens 318, side ports 316 b, and tubing 324 b. The “Y”fitting 230 may coupled to a delivery line (not shown), as describedelsewhere herein for delivering the sealing compound into a puncture.

[0116] It will be appreciated that the valve 310 may facilitate a userfilling the syringes 332 with a desired volume of sealing compound froma vial 322 or other source with the valve 310 in a loading position,including allowing mixing and/or reconstituting sealing components.During use, the valve 310 may simply be moved to a delivery position toallow the sealing compound to be delivered. In addition, if desired, thevalve 310 may have a third position where the lumens 318 do notcommunicate with either of the side ports 316 a, 316 b, therebysubstantially eliminating the risk of precursor polymer materialsescaping from the syringes 332 and/or mixing prematurely.

[0117] Such a valve 310 may be convenient to use for a manually infectedsystem, such as those described above. In addition or alternatively,such valves may be particularly convenient for an auto-injector system,i.e., a system that automatically delivers a sealing compound once thesystem is triggered or otherwise activated, as described further below.

[0118] It will be appreciated that other valve configurations may beprovided instead of the linear valve and tubing arrangement shown inFIGS. 15, 16A, and 16B, such as a stopcock or rotating valve. Forexample, FIGS. 17A-17C show an embodiment of a revolver valve 410 thatmay be provided, including a valve body 414 (shown in phantom) rotatablewithin a housing 412. The valve 410 includes ports 420 (shown inphantom) that may be connected to syringes of a delivery device (notshown), and first and second sets of ports 416 a, 416 b that may beconnected to respective vials and a “Y” fitting (also not shown),respectively, e.g., by tubing (not shown), similar to the previousembodiment.

[0119] Internal lumens or passages (not shown) in the body 414communicate with the ports 420 and may selectively communicate with theports 416 a or 416 b, depending upon the position of the body 414relative to the housing 412. For example, with the body 414 in the firstposition shown in FIG. 17A, the ports 420 do not communicate with eitherof the other ports 416 a, 416 b, and the valve 410 is closed or off.When the body 414 is rotated to the second position shown in FIG. 17B,the ports 420 communicate with the ports 416 a, allowing syringes to befilled from vials, as described above. Finally, when the body 414 isrotated to the third position shown in FIG. 17C, the ports 420communicate with the ports 416 b, creating a passage through which theprecursor polymers may be injected from syringes through a “Y” fittingand into a patient (not shown), as described above.

[0120] Turning to FIGS. 1 and 9, an embodiment of a retraction assembly10 is shown that generally includes a housing 112 to which the occlusionmember 4 may be secured, a shaft 114 slidably coupled to the housing 112and the introducer sheath assembly 6, and a lock/release mechanism 116for controlling movement of the shaft 114 relative to the housing 112.The housing 112 may include one or more connectors (not shown) forsecuring the occlusion member 4 to the housing 112. For example, thehousing 112 may include a recess for receiving the hub subassembly 38 ofthe occlusion member 4 therein and/or one or more catches, detents, andthe like (not shown) for releasably or substantially permanentlysecuring the occlusion member 4 thereto. Alternatively, the occlusionmember 4 may be incorporated into or otherwise substantially permanentlyattached to the retraction assembly 10.

[0121] The introducer sheath assembly 6 may be slidably disposed overthe occlusion member 4 before or after the occlusion member 4 is securedto the retraction assembly 10. For example, the occlusion member 4 maybe mounted to the retraction assembly 10 during manufacturing such thatthe shaft 114 extends distally adjacent to the outer member 12 of theocclusion member 4. The shaft 114 and the introducer sheath assembly 6may include one or more connectors for releasably or substantiallypermanently connecting the shaft 114 to the introducer sheath assembly6.

[0122] For example, a distal end 121 of the shaft 114 may include ahook, tab, or other element (not shown) that may be received in a holeor pocket (also not shown) in the flange 104 on the introducer sheathassembly 6. During a procedure, as described further below, the balloon80 of the occlusion member 4 may be inserted into the housing 98 andadvanced distally through the lumen 96 of the introducer sheath 90 untilthe balloon 80 extends beyond the distal end 94 of the introducer sheath90. The distal end 121 of the shaft 114 may then be attached to theflange 104. Once the shaft 114 is attached to the flange 104, axialmovement of the introducer sheath assembly 6 may be coupled to axialmovement of the shaft 114.

[0123] Optionally, the apparatus 2 may include a cover (not shown) forconcealing the various components of the retraction assembly 10, alongwith the components of the occlusion member 4 and/or introducer sheathassembly 6 to which users do not need access.

[0124] With additional reference to FIGS. 10A and 10B, the housing 112of the retraction assembly 10 may include a passage 118 therein thatextends substantially parallel to the longitudinal axis 20. A proximalend 120 of the shaft 114 may be slidably received in the passage 118,while the distal end 121 of the shaft 114 may be coupled to theintroducer sheath assembly 6, e.g., to the flange 106, as describedabove. The shaft 114 may be biased to move within the passage 118 tobias axial movement of the introducer sheath 90 coupled to theretraction assembly 10. For example, a compression spring 122 or otherelement may be provided in the passage 118 for biasing the shaft 114proximally relative to the housing 112.

[0125] The lock/release mechanism 116 may include a lock member 124 thatis disposed within the housing 112 and that is movable transverselyrelative to the passage 118. A spring or other mechanism (not shown) maybe provided for biasing the lock member 124 outwardly such that arelease button 126 of the lock member 124 extends through an opening 128in the housing 112. The release button 126 may include a sloped outerproximal surface 126 a, e.g., to convert an axial force from the piston135 of the plunger assembly 130 into a transverse force for moving thelock member 124 inwardly.

[0126] The lock member 124 may include connectors for releasablysecuring the shaft 114 at one or more positions within the passage 118.For example, the lock member 124 may include an aperture 125 throughwhich a portion of the shaft 114 may extend. When the shaft 114 is in adistal position and the lock member 124 is in an outer locked position(shown in FIG. 10A), the lock member 124 may engage the shaft 114 toprevent the shaft 114 from moving axially within the passage 118. Forexample, a portion of the lock member 124 may simply frictionally engagethe shaft.114. Alternatively, the lock member 124 and shaft 114 mayinclude one or more cooperating detents (not shown) that engage oneanother when the lock member 124 is in the outer locked position.

[0127] When the lock member 124 is pushed inwardly, e.g., when therelease button 126 is depressed (shown in FIG. 10B), the shaft 114 maybe released from the lock member 124 and free to move axially within thepassage 118. Because of the bias provided by the spring 122, the shaft114 may move proximally within the passage 118 until the proximal end116 of the shaft 114 reaches the end of the passage 118 or encounters astop (not shown), preventing further proximal movement.

[0128] Because the shaft 114 is coupled to the introducer sheathassembly 6 (not shown, see FIGS. 1 and 9), when the shaft 114 is lockedin the distal position, the introducer sheath 90 may be secured relativeto the outer member 12. For example, in the distal position, the distalend 94 of the introducer sheath 90 may be located a predetermineddistance proximal to the balloon 80 of the occlusion member 4, as shownin FIG. 1. Once the shaft 114 is released and moves proximally, theintroducer sheath 90 is directed proximally, thereby moving the distalend 94 of the introducer sheath 90 away from the balloon 80 of theocclusion member 4 (not shown). As explained further below, the distancethat the introducer sheath 90 is moved by the shaft 114 preferablycorresponds generally to the length of a puncture or other tract throughtissue that is being sealed by the apparatus 2.

[0129] Returning to FIG. 1, the lock member 124 is preferably releasedautomatically as sealing compound is being delivered from the deliverydevice 8. To accomplish this, in the embodiment shown, the deliverydevice 8 includes piston 135 extending from the plunger assembly 133. Ascan be seen in FIG. 1, the piston 135 is preferably aligned axially withthe release button 126 extending from the housing 112 of the retractionassembly 10. Thus, when a user depresses the plunger assembly 133, thepiston 135 may contact the sloped proximal surface 126 a of the releasebutton 126. As the plunger assembly 133 is depressed further, as shownin FIG. 10B, the piston 135 may bear against the sloped proximal surface126 a, thereby directing the release button 126 and, consequently, thelock member 124 inwardly to release the shaft 114.

[0130] Preferably, the distance between the piston 135 and the releasebutton 126 is predetermined such that the lock member 124 is released ata desired time during the stroke of the plunger assembly 133. Forexample, as explained further below, as the plunger assembly 135 isdepressed, the components in the syringe barrels 132 may be injectedthrough the “Y” fitting 140, into the housing 98 of the introducersheath assembly 6, and through the lumen 96 of the introducer sheath 90.Once the mixed sealing material begins to exit the distal end 94 of theintroducer sheath 90, the lock member 124 may be released to allow theintroducer sheath 90 to retract proximally, thereby filling a puncturewithin which the introducer sheath 90 is disposed with the sealingmaterial.

[0131] Turning to FIG. 18A-18C, another embodiment is shown of anapparatus 502 that includes an occlusion member 504, an introducersheath 506, a delivery device 508, and a retraction assembly 510. Theocclusion member 504 may be releasably or substantially permanentlyattached to the retraction assembly 510, similar to the previousembodiments. The introducer sheath 506 may be a conventional introducersheath or may be similar to other embodiments described herein. Thedelivery device 508 may be a dual-syringe assembly, including manualinjection or automatic injection, also similar to other embodimentsdescribed herein.

[0132] Similar to the previous embodiments, the retraction assembly 510may include a housing 512 to which the occlusion member 504 may besecured, a shaft 514 slidably coupled to the housing 512, and alock/release mechanism (not shown) for controlling movement of the shaft514 relative to the housing 512, e.g., based upon use of the deliverydevice 508. Also, similar to the previous embodiments, the occlusionmember 504 may include an outer member 512 and a balloon 580 carried ona distal end 516 of the outer member 512. The occlusion member 504 mayinclude one or more of the other components described above with respectto other embodiments.

[0133] Unlike the previous embodiments, the retraction assembly 510includes a delivery sheath 530 that surrounds and is slidable relativeto a proximal portion of the outer member 516. The delivery sheath 530includes a distal end 532 having a size and shape allowing the deliverysheath 530 to be inserted into a lumen 507 of the introducer sheath 506.

[0134] The delivery sheath 530 is coupled to the shaft 514 such thataxial movement of the delivery sheath 530 corresponds to movement of theshaft 514. For example, a distal end 515 of the shaft 514 and a proximalend 531 of the delivery sheath 530 may include cooperating connectors(not shown) for releasably or substantially permanently coupling theshaft 514 and the delivery sheath 530 to one another, similar to theconnectors described above for the shaft 114 and introducer sheathassembly 6 shown in FIG. 1.

[0135] The delivery sheath 530 also includes a pair of detents 534located a predetermined distance from the distal end 532 for couplingthe delivery sheath 530 to the introducer sheath 506. In an exemplaryembodiment, best seen in FIGS. 18B and 18C, each detent 534 is a stripof spring material, e.g., a pseudoelastic and/or superelastic material,such as stainless steel or Nitinol, that has a fixed end attached to thedelivery sheath 530, and a free end 534 a formed into a loop.Alternatively, both ends of the detent may be fixed, yet define a loop(not shown). Because of the elasticity of the spring material, thedetent 534 may be collapsed against the delivery sheath 530, e.g., ifthe loop is unrolled or collapsed, yet may resume its looped shape whenany external force is removed.

[0136] As described above with respect to earlier embodiments, theintroducer sheath 506 may include a housing 550 defining a cavity 552and including a side port 554 communicating with the cavity 552 and,consequently, with the lumen 507 of the introducer sheath 506. Thehousing 550 may also include one or more seals (not shown) forsubstantially sealing the cavity 552, yet allowing one or moreinstruments, e.g., the occlusion member 504 and/or the delivery sheath530 to be inserted into the lumen 507.

[0137] As shown in FIG. 18B, when the delivery sheath 530 is advancedinto the introducer sheath 506, the detents 534 may contact the housing550, causing the free ends 534 a to unroll as the detents 534 enter thehousing 550. Once the detents 534 are located completely within thecavity 552, the free ends 534 a may resume their looped shape.Alternatively, if both ends of the detents are fixed, the detents maysimply collapse as they are directed into the housing 550 and thenresilient return to their looped shape once located within the cavity552. Thereafter, if the delivery sheath 530 is directed proximally awayfrom the introducer sheath 506, the detents 534 may contact the wall ofthe housing 550, preventing the delivery sheath 530 from being removedeasily from the introducer sheath 530. Thus, proximal movement of thedelivery sheath 530 will cause proximal movement of the introducersheath 506.

[0138] Although a pair of detents 534 are shown opposite one another onthe delivery sheath 530, it will be appreciated that one or more detentsmay be provided at one or more locations around the delivery sheath 530for coupling to the introducer sheath 506. In addition or alternatively,additional connectors may be provided, such as ramped tabs and the likeinstead of the spring loops described above.

[0139] Optionally, as shown in FIGS. 18B and 18C, the delivery sheath530 may also include an annular seal 536 adjacent to, and preferably,distal to the detents 534. The seal 536 may be a solid mass of resilientmaterial, e.g., plastic, foam rubber, and the like, e.g., formed into atapered wedge shape contoured to provide sufficient interference withthe interior of the housing 550. Alternatively, the seal 536 may be aballoon or other membrane that may be filled with a desired volume offluid, e.g., saline, nitrogen, carbon dioxide, and the like. When thedelivery sheath 530 is inserted into the introducer sheath 506, the seal536 may compress sufficiently to allow the seal 536 to enter the cavity552. As the delivery sheath 530 is advanced to engage the detents 534within the housing 550, the seal 536 may substantially engage aninterior of the housing 550 and/or introducer sheath 506. Thus, the seal536 may substantially seal the lumen 507 of the introducer sheath 506from fluid flow distally between the delivery sheath 530 and theintroducer sheath 506. One advantage of such a seal 536 is that it mayallow a delivery sheath 530 having a fixed size to be inserted into avariety of sized introducer sheaths, while still substantially sealingthe lumen of the introducer sheaths.

[0140] In the embodiment shown in FIGS. 18B and 18C, the delivery sheath530 may include one or more openings 538 (a pair being shown) adjacentthe detents 534 and communicating with a lumen 540 extending to thedistal end 532 of the sheath 530. In this embodiment, the deliverysheath 530 may have sufficient length such that, when the deliverysheath 530 is fully received in the introducer sheath 506, the distalend 532 may extend beyond the distal end (not shown) of the introducersheath 506. Sealing compound may be injected into the side port 554 ofthe housing 550 using any of the delivery devices described herein. Withthe lumen 507 of the introducer sheath 506 sealed by the seal 536, theinjected sealing compound may be forced through the openings 538 intothe lumen 540 and out the distal end 532 of the delivery sheath 530.

[0141] Optionally, the delivery sheath 530 and the occlusion member 4may include cooperating detents, connectors, or other features (notshown) for limiting distal movement of the delivery sheath 530 relativeto the occlusion member 4. For example, the delivery sheath 530 may bemovable distally until the cooperating features contact one another,e.g., such that the distal end 532 of the delivery sheath 530 is locateda minimum distance from the balloon 80 of the occlusion member 4, e.g.,at least about five millimeters (5 mm). Such features may prevent thedelivery sheath 530 from being directed against or too close to theballoon 80, which may increase the risk of sealing material beingdelivered into the vessel (not shown), as explained further below.

[0142] Alternatively, if the seal 536 and openings 538 are eliminatedfrom the delivery sheath 530, the length of the delivery sheath 530 maybe reduced to have a relatively short length compared to the introducersheath 506, e.g., sufficient to engage the detents 534 within thehousing 550. In this alternative, when sealing compound is injected intothe side port 554, the sealing compound may pass along the lumen 507 ofthe introducer sheath 506 and out its distal end (not shown). Thus, ashortened delivery sheath may simply be a connector for couplingmovement of the introducer sheath 506 to the retraction assembly 510.

[0143] In a further alternative, a sheath, similar to the deliverysheath 530 described above, may be utilized in an embodiment without aretraction assembly. In such an embodiment, the delivery sheath mayinclude an enlarged handle on its proximal end to facilitate manualmanipulation of the delivery sheath once it is coupled to the introducersheath. For example, the delivery sheath may be inserted into theintroducer sheath until the detents enter the housing of the introducersheath, thereby coupling subsequent movement of the introducer sheath tothe delivery sheath.

[0144] Optionally, the delivery sheath may include a seal in itsproximal end, allowing an occlusion member to be inserted into thedelivery sheath, and consequently, through the introducer sheath, usingthe methods described elsewhere herein. Thus, the delivery sheath may bedrawn proximally while sealing compound is being delivered through theintroducer sheath, thereby manually retracting the introducer sheath andat least partially filling a puncture with sealing compound.

[0145] Turning to FIGS. 11A-11F, an exemplary method for sealing apassage through tissue is shown using an apparatus similar to that shownin FIG. 1. In the shown embodiment, the passage is a percutaneouspuncture 190 extending from a patient's skin 192 to a blood vessel orother body lumen 194. For example, the vessel 194 may be a peripheralartery, e.g., a femoral artery, a carotid artery, and the like. It willbe appreciated that the apparatus and methods in accordance with thevarious embodiments of the present invention may be used to seal otherpassages within a patient's body.

[0146] Initially, as shown in FIG. 11A, the introducer sheath 90 of theintroducer sheath assembly 6 may be placed within the puncture 190 suchthat the distal end 94 is disposed within the vessel 192 without theother components of the apparatus 2. The introducer sheath 90 may beintroduced within the puncture 190 using conventional methods, such asthose used to insert known introducer sheaths. Alternatively, a separateintroducer sheath (not shown) may be inserted into the puncture 190using known procedures.

[0147] One or more instruments (not shown) may be advanced through theintroducer sheath 90 (or separate introducer sheath) and into the vessel194, e.g., to perform one or more diagnostic and/or therapeuticprocedures within the patient's body. The one or more instruments mayinclude catheters, e.g., balloon catheters, stent delivery catheters,imaging catheters, and the like, guidewires, and/or other devices. Uponcompleting the procedure(s), any instruments may be removed and thepuncture 190 may be sealed using an apparatus, such as that shown inFIGS. 1-6 and described above.

[0148] Turning to FIG. 11B, with the balloon 80 in the collapsed state,the occlusion member 4 may be inserted through the lumen 96 of theintroducer sheath 90 until the balloon 80 is disposed within the vessel194. Once the occlusion member 4 is inserted sufficient distance, theretraction assembly 10 may be coupled to the introducer sheath assembly6. For example, the shaft 114 may include a hook or other connector (notshown) that may be easily coupled to the flange 104 of the introducersheath assembly 6, as described above. Alternatively, if a separateintroducer sheath is provided, this introducer sheath may be removed,and the apparatus 2, preassembled by the manufacturer or by the userbefore use (e.g., such that the introducer sheath assembly 6 is disposedover the occlusion member 4 and is coupled to the retraction assembly10), may be inserted into the puncture 190. In a further alternative, aretraction assembly with a delivery sheath surrounding the occlusionmember (not shown) may be coupled to the introducer sheath 90 bycoupling the delivery sheath to the introducer sheath 90, as describedabove.

[0149] With the balloon 80 collapsed, the occlusion member 4 may beinserted through the introducer sheath 90 into the puncture 190, e.g.,freely or over a guidewire (not shown), until the balloon 80 exits thedistal end 94 of the introducer sheath 90 and is advanced into thepuncture 190. optionally, the apparatus 2 may include one or moremarkers, e.g., radiopaque markers (not shown) on the outer member 12 ofthe occlusion member 4 and/or on the introducer sheath 90, to facilitatemonitoring insertion of the apparatus 2 using external imaging, e.g.,fluoroscopy, ultrasound, magnetic resonance imaging (“MRI”), and thelike. Alternatively or in addition, one or more visual markers (notshown) may be provided, e.g., on the proximal end 14 of the outer member12 and/or the introducer sheath 90.

[0150] As shown in FIG. 11C, once the balloon 80 is disposed within thevessel 194, the balloon 80 may be expanded to the expanded state. Forexample, fluid may be introduced into the side port 44 from a syringe160 through the outer member 12 and into the balloon 80. As explainedabove, as fluid is introduced into the side port 44, the inner member 32may be moved proximally relative to the outer member 12, thereby causingthe balloon 80 to shorten as it expands. Preferably, the fluid isintroduced until the piston 60 moves proximally and markers 77, 78 arealigned with one another, as shown in FIG. 11C, to inform the user thata desired pressure has been reached and/or that the balloon 80 has beenexpanded to a desired size. Alternatively, the occlusion member 4 mayinclude a pressure gauge or other indicator (not shown) that may providethe user visual confirmation that the balloon 80 has been expanded to adesired size and/or configuration. Alternatively, the occlusion membermay include a reservoir of fluid that is delivered into the balloon 80when an actuator is activated, as described elsewhere herein withrespect to FIGS. 12A-12C.

[0151] Turning to FIG. 11D (which omits the proximal components of theapparatus 2 merely for simplicity), the apparatus 2 may be partiallywithdrawn from the puncture 190 with the balloon 80 in the expandedstate, i.e., until the balloon 80 engages the puncture 190. Preferably,the balloon 80 substantially seals the puncture 190, i.e., substantiallyisolating the puncture 190 from the interior of the vessel 194. Thus,the apparatus 2 may provide temporary hemostasis, e.g., preventing bloodfrom passing through the puncture 190. Even without the additional stepsthat follow, the apparatus 2 may be used to provide hemostasis inemergency situations in order to minimize loss of blood until a puncturevictim may be treated.

[0152] In one embodiment, the balloon 80 at least partially everts inthe expanded state, as described above. This everted configuration maybe particularly useful for providing hemostasis, while still allowingblood flow to continue along the vessel 194. For example, as shown inFIG. 11D, the diameter of the balloon 80 may be substantially greaterthan its length in the expanded state. Thus, when the balloon 80 ispulled into engagement with the wall 196 of the vessel 194, at least aportion of the vessel 194 lumen may remain unobstructed, as shown.

[0153] Optionally, in order to maintain the balloon 80 substantiallyagainst the puncture 190 without requiring an individual to hold theapparatus 2, a tensioner 250 may be provided that may apply asubstantially constant proximal force to the apparatus 10 to maintainthe balloon 80 substantially against the puncture 190. For example, asshown in FIGS. 13, 14A, and 14B, the tensioner 250 may include a baseportion or bottom foot 251, a support 252, and a saddle or top foot 256.The base portion 251 may be substantially flat or shaped to conform tothe patient's anatomy, e.g., to follow the contour or otherwise lie on apatient's leg (not shown) or other skin 192 overlying the puncture 190.

[0154] The saddle 256 may include a slot 258 or other mechanism forgrasping or otherwise engaging the occlusion member 204. For example, asshown in FIGS. 14A and 14B, the saddle 256 may include fingers 257defining the slot 258. The slot 258 may have a width large enough toreceive the occlusion member 204 therein, e.g., to receive a cover 239surrounding the hub subassembly 238, while the fingers 257 are slidablyreceived in grooves 241 in the cover 239.

[0155] The support 252 may include a substantially rigid stabilizer wireor other shaft 253, and a spring housing 254 that is slidably coupled tothe saddle 256. The spring housing 254 may allow the length of thetensioner 250 to be adjustable while maintaining a substantiallyconstant and known force on the occlusion member 204, thereby allowingthe distance between the base support 251 and the saddle 256 to beadjusted based upon particular anatomy encountered during a procedurewhile maintaining a desired tension on the occlusion member 204.

[0156] As best seen in FIG. 13, the spring housing 254 may include acylinder 260 extending from the stabilizer-wire 253 and a piston 262slidably received therein that extends from the saddle 256. A spring 264or other biasing mechanism may be provided in the cylinder 260 forbiasing the piston 262, and consequently, the saddle 256, away from thefoot 251. Flange 266 may extend from the cylinder 260, allowing the biasof the spring 264 to be overcome by manual force, thereby causing thesaddle 256 to move towards the foot 251, i.e., shortening the tensioner250.

[0157] During use, the base portion 251 may be placed in contact withthe patient, e.g., set on the patient's skin 192 adjacent to thepuncture 190 (not shown, see generally, e.g., FIGS. 11A-11F). The saddle256 may be pushed towards the foot 251 by moving flange 266 towardsflange 265, e.g., until the piston 262 bottoms out in the cylinder 260.An occlusion member, such as 4 or 204, may be received in the saddle256, e.g., by aligning the fingers 257 with a corresponding groove 241in the cover 239. Once the occlusion member 4, 204 is engaged, theflange 266 may be released, and the bias of spring 264 may direct thesaddle 256 away from the foot 251. Once the occlusion member 4, 204resists movement of the saddle 256, i.e., matching the force from thespring 264, the tensioner 250 will stabilize and maintain the desiredtension on the occlusion member 4, 204 against the wall. 196 of thevessel 194.

[0158] Once the tensioner 250 is adjusted, the occlusion member 4 or 204may be released, and the tensioner 250 may pull the occlusion member 4or 204 10 proximally with sufficient tension to maintain the balloon 80in contact with the wall 196 of the vessel 194. If necessary, thebiasing support 252 may be adjusted to increase or decrease the distancebetween the saddle 256 and the base support 252 and/or to increase ordecrease the tension as necessary for the anatomy encountered. Thus, thetension imposed by the tensioner 250 may apply a desired tensile forceto the balloon 80 to maintain hemostasis while preventing the balloon 80from being pulled into the puncture 190 and/or preventing the wall 196of the vessel 194 from excessive tenting. Preferably, the spring 264 hasa constant spring constant as it compresses and extends, therebyapplying a constant force to the balloon 80.

[0159] It will be appreciated that other configurations may be providedfor the tensioner 250 than that shown in FIGS. 13-14B. For example, thesaddle may be slidable along the shaft connected to the foot, and aconstant force spring, e.g., a coil spring, extension spring,compression spring, and the like,,may be coupled between the saddle andthe shaft to bias the saddle away from the foot or otherwise as desired.Alternatively, the spring may provided a variable force along themovement range of the saddle, e.g., providing greater or lesserresistance as the saddle is directed towards the foot.

[0160] Turning to FIG. 11E, once the occlusion member 4 is adjusted toseal the puncture 190 from the vessel 194, a sealing compound 146 may bedelivered into the puncture 190. Preferably, the sealing compound is aliquid or other flowable material that may be injected into the puncture190. Because of the hemostasis provided by the balloon 80, the sealingcompound 146 may be delivered without substantial concern that thesealing compound 146 may leak into the vessel 194. As explained above,relative movement of the introducer sheath 90 and the occlusion member 4may be limited to maintain a minimum distance between the distal end 96of the introducer sheath 90 and the balloon 80. This may reduce the riskof sealing material being injected into the vessel 194.

[0161] The sealing compound may include multiple precursor polymercomponents that create a hydrogel when mixed together, as describedabove. Such a sealing compound may be particularly useful, because itmay be substantially harmless to the patient even if it somehow leaksinto the vessel 194. Unlike collagen or other hemostasis-promotingmaterials, which may cause thrombosis and/or embolism when exposed toblood within a vessel, hydrogel polymers may not promote hemostasiswithin a blood vessel. In fact, such hydrogels, if leaked into a vessel,may simply dilute and flow away, where they may be metabolized naturallywithout substantial risk of creating thrombus. This is another reasonwhy it may be useful to seal the puncture 190 with an everted balloon80, while still allowing fluid to continue to flow along the vessel 194,as described above. In case the hydrogel leaks into the vessel 194around the balloon 80, blood flow may dilute and carry the hydrogelaway, where it may be safely metabolized naturally.

[0162] As shown in FIG. 11E, a two-part sealing compound is showncontained within the dual syringe assembly 130. The precursor polymersor other components in the syringe barrels 132 may be mixed or otherwiseprepared before the procedure using known methods. The plunger assembly133 may be manually depressed, thereby advancing the plungers 134substantially simultaneously, and delivering the precursor polymercompounds simultaneously. The precursor polymers may mix in the “Y”fitting 140 into a liquid sealing compound 146, and then be deliveredinto the side port 102 of the introducer sheath 90 via the mixer 110 andtubing 106. Alternatively, an auto-injector device (not shown) may beprovided for delivering the precursor polymers at a desiredsubstantially continuous rate, as described further below.

[0163] The liquid sealing compound 146 may be injected through the lumen96 of the introducer sheath 90 out the distal end 94 into the puncture190. As the plunger assembly 133 is depressed, the piston 135 mayslidably engage the release button 126, e.g., bearing against the slopedproximal surface 126 a (not shown, see FIGS. 10A and 10B). This causesthe lock member 124 to move inwardly, thereby releasing the shaft 114,as described above. Once the shaft 114 is released, the spring 122 maycause the shaft 114 to move proximally. This may cause the introducersheath 90 to be withdrawn proximally from the puncture 190 as thesealing compound 146 is delivered, thereby filling the puncture tractwith the sealing compound 146, as shown in FIG. 11F. Proximal movementof the shaft 114 is preferably limited, e.g., to prevent the introducersheath 90 from being withdrawn completely from the puncture 190 as thesealing compound 146 is delivered.

[0164] It will be appreciated that other devices may be used fordelivering sealing material into the puncture 190. For example, otherapparatus for delivering liquid sealing compounds, including single ormultiple lumens (not shown), may be advanced over the occlusion member 4instead of the single lumen introducer sheath 90.

[0165] Turning to FIG. 11F, once the sealing compound 146 is delivered,the sealing compound 146 may be given sufficient time to at leastpartially (or fully) solidify or gel, e.g., between about five and onehundred eighty (5-180) seconds. The balloon 80 may then be deflated tothe collapsed state and then withdrawn from the puncture 190. Asdescribed above, the balloon 80 may preferably be extended-distally asit collapses to facilitate its removal through the sealing compound 146delivered into the puncture 190 optionally, to facilitate removing theocclusion member 4, a lubricious coating (not shown) may be provided onthe exterior of the outer member 12, sheath 530 (not shown, see FIG.18A), and/or balloon 80, e.g., Dow 360 silicone fluid. Such a coatingmay prevent the sealing compound 146 from sticking to or otherwisepulling on the occlusion member 4 as it is withdrawn optionally,external pressure may be applied, e.g., by pressing manually against theskin 192 overlying the vessel 194, e.g., to at least partially suppressflow through the vessel 194. The balloon 80 (and the rest of theapparatus 10) may be removed, and the external pressure may bemaintained for sufficient time to allow the sealing compound 146 tosolidify further, e.g., between about ten and one hundred eighty(10-180) seconds. The sealing compound may expand, e.g., due to itselasticity and/or due to further solidification, thereby substantiallysealing the relatively small tract remaining upon removing the apparatus10.

[0166] Alternatively, the tensioner 150 (not shown, see FIGS. 13A-14B)may be used to maintain tension on the balloon 80 for a prolonged periodof time with the balloon 80 providing temporary hemostasis to allow thehydrogel to cure fully in the puncture 190 before removing the apparatus10.

[0167] Turning to FIGS. 19A-19C, an exemplary embodiment of a deliverydevice 608 for automatically delivering sealing compound is shown thatmay be provided instead of a manually injected system, such as thosedescribed above. In the embodiment shown, the delivery device 608 (whichmay also be referred to as an auto-injector assembly) includes a pair ofsyringe barrels 632 including outlets 636 and defining a longitudinalaxis 620. It will be appreciated that the delivery device 608 mayinclude one or more syringe barrels, depending upon the type of sealingcompound being delivered.

[0168] A plunger assembly 133 is slidable axially relative to thebarrels 636. In one embodiment, the plunger assembly 633 includes a pairof plungers 634 that are coupled to one another yet are received inrespective barrels 632. Thus, both plungers 134 may be advanced into orretracted from the barrels 632 substantially simultaneously with oneanother.

[0169] The delivery device 608 also includes a spring mechanism 640(best seen in FIG. 19B) that may be activated to cause the plungerassembly 633 to advance automatically into the barrels 632. As shown,the spring mechanism 640 includes a spring 642 disposed around a shaft644 extending from the plunger assembly 633. The spring 642 is disposedadjacent to a hub or barrel plate 646 extending between the barrels 632,thereby fixing a first or upper end of the spring 642 relative to thebarrels 632. The shaft 644 extends distally from the plunger assembly633 between the barrels 632, and terminates in an enlarged head 648.Preferably, the head 648 is larger than the diameter of the spring 642and/or includes one or more radial elements (not shown) against whichthe spring 642 may push when released.

[0170] The spring mechanism includes an actuation button 650 that may becoupled to an interference plate 652 that extends transversely relativeto the longitudinal axis 620 such that the spring 642 is disposedbetween the plate 646 and the interference plate 652. In the embodimentshown, the actuation button 650 and interference plate 646 areintegrally molded or otherwise formed as a single piece, althoughalternatively, they may be separate pieces attached to one another.

[0171] In one embodiment, the spring 642 is a compression spring that iscompressed when disposed initially between the plate 646 and theinterference plate 652. The actuation button 650 and interference plate652 are movable from a first locked or outer position, and a secondrelease or inner position.

[0172] The interference plate 652 includes a passage 654 extendingaxially therethrough that has cross-section larger than the diameter ofthe spring 652. In the first position, the passage 654 is offset fromthe spring 652, such that a second or lower end of the spring 652 bearsagainst the interference plate 652. When the actuation button 650 isdirected to the second position, the passage 654 becomes aligned withthe spring 652. This action releases the spring 652, allowing the springto pass through the passage 654 and push against the head 648,thereby-directing the head 648, and consequently the shaft 644, distallyrelative to the barrels 632. As the shaft 644 moves distally, theplunger assembly 633 is advanced into the barrels 632 to inject thesealing compounds out of the barrels 632 through the outlets 636.

[0173] Optionally, the delivery device 608 may include a cover or casing656 that may at least partially enclose the spring mechanism 640 and/orthe barrels 632. In addition, the delivery device 608 may include avalve, tubing, containers storing sealing components, a “Y” fitting,and/or a mixer, similar to the embodiments described above. For example,FIGS. 16A and 16B show an embodiment of a delivery device 308, includinga spring mechanism 340 similar to that described above.

[0174] With reference to the delivery device 308 shown in FIGS. 16A and16B, during use, sealing components may be provided in the barrels 332with the plunger assembly 333 in a first proximal position. For example,initially, one or more solvents, buffer solutions, and/or other sealingcomponents may be provided in the syringe barrels 332, e.g., filledduring manufacturing. Vials 320 may be provided that include additionalsealing components that may be mixed or reconstituted with the sealingcomponents in the barrels 332.

[0175] Shortly before delivering the sealing components, the valve 310may be moved to a firsts position wherein the outlets 336 of the barrels332 communicate with the vials 322. The plunger assembly 333 may bemanually advanced into the barrels 332 to inject the sealing componentsin the barrels 332 into the vials 322. In one embodiment, the solventsor buffer solutions in the barrels 332 are injected into the vials 322that include solid polymer precursor components, for example, in powderor other solid form, to reconstitute or otherwise mix the precursorpolymer components.

[0176] Once the buffer solution is injected into the vials 322, thevials 322 may be shaken, e.g., by shaking the entire delivery device308, to dissolve the polymer precursor components in the one or morebuffer solutions. Once the sealing components are mixed and/orreconstituted, the plunger assembly 333 may be manually withdrawn atleast partially from the barrels 332 to draw the mixed sealingcomponents from the vials 322 into the barrels 332. Preferably, theplunger assembly 333 is withdrawn a predetermined distance to a load adesired volume into the barrels 332 based upon the volume of thepuncture to be sealed.

[0177] Once the reconstituted/mixed sealing components are loaded in thebarrels 332, the valve 320 may be moved to a closed position, and thedelivery device 308 may be set aside, e.g., while one or more medicalprocedures may be performed on the patient. Upon completing theprocedure(s), the valve 320 may be moved to a delivery position, whereinthe outlets 336 communicate with the “Y” fitting 339 and delivery line(not shown) that communicates with a delivery sheath (also not shown),such as any of the devices described elsewhere herein.

[0178] At the time of delivery, the actuation button 350 may beactivated to release the spring 342, which may then push on the shaft344, thereby advancing the plunger assembly 333 into the barrels 332,and injecting the sealing components out of the barrels 332. Oneadvantage of an auto-injector delivery device, such as those describedherein, may prevent unintended pauses during delivery. Suchinterruptions risk occluding the delivery line, i.e., the “Y” fitting,mixer, or other passages through which the sealing compound passes. Thismay be a particular concern where the sealing compound has a relativelyshort gel or set-up time. The spring constant of the spring mechanismmay be predetermined to ensure that the sealing compound is delivered ina desired time, i.e., before the sealing compound gels and ceases toflow through the delivery line.

[0179] Turning to FIGS. 20A-20F, another embodiment of an auto-injectorassembly 708 is shown. Similar to the previous embodiment, the assembly708 includes a pair of syringe barrels 732 including outlets 736 and aplunger assembly 733 slidable relative to the barrels 732. The plungerassembly 733 includes a pair of plungers 734 slidably disposed in thebarrels 732, and a pair of pistons 735 slidable within the barrels 732relative to the plungers 734. Springs 637 are also provided within thebarrels 732 that are coupled between the plungers 734 and the pistons735. It will be appreciated that the barrels 732, plungers 734, and/orpistons 735 may include one or more connectors, e.g., detents, stops,and the like (not shown) that limit relative movement of the partsrelative to one another and/or prevent the assembly 708 from comingapart during use.

[0180] The springs 737 may have a predetermined spring constant suchthat the plungers 734 and pistons 735 may be directed towards oneanother, when axial forces are applied. When the forces are removed, thesprings 737 bias the plungers 734 and pistons 735 to move away from oneanother to return to the springs 737 a relaxed state.

[0181] The plungers 734 and/or the barrels 732 may include cooperatingconnectors or other locking elements (not shown) that may be selectivelyactivated to secure the plungers 734 relative to the barrels 732, e.g.,to lock the plungers 734 in a depressed position where the plungers 734are advanced into the barrels 732. The locking elements may includecooperating detents, ratchets, latches, and the like (not shown), as isknown in the art.

[0182] In one embodiment, shut-off valves (not shown) may be provided inthe outlets 736 to selectively open and close the outlets 736.Alternatively, a multiple port valve, such as those shown in FIGS. 15and 17A-17C, may be provided that eliminate the need to changeconnections to the outlets 736 during a procedure.

[0183] Initially, before use, the assembly 708 is provided with sealingcomponents in the barrels 708, e.g., one or more solvents or buffersolutions, as shown in FIG. 20A. The barrels 708 may include apredetermined volume intended to be mixed with powdered or other solidpolymer precursor components, e.g., provided in vials 322, similar tothe previous embodiments. With the barrels 708 filled with the sealingcomponents, the pistons 735 and plungers 735 may be retracted from thebarrels 708 such that the springs 737 are substantially relaxed.Alternatively, if the springs 737 are not fully relaxed, the valve 710may be closed to prevent the sealing components from being injected outof the barrels 708 by the potential of the springs 737.

[0184] Shortly before use of the assembly 708, e.g., while preparing fora medical procedure involving creation of a puncture through tissue thatis to be sealed, the valve 710 may be positioned such that the outlets736 communicate with the vials 722. In one embodiment, the vials 722 maybe provided already attached to the assembly 708, similar to theembodiment shown in FIGS. 16A and 16B. Alternatively, the vials 722 maybe attached to the valve 710 or even directly to the outlets 736.

[0185] As shown in FIG. 20B, the sealing components in the barrels 732may be injected into the vials 722 by depressing the plunger assembly733, advancing the pistons 735 distally. The sealing components may bemixed and/or reconstituted in the vials 722, similar to the previousembodiments. Once mixed, the plunger assembly 733 may be retracted todraw a desired volume of the mixed sealing components into the barrels732, as shown in FIG>20C.

[0186] The assembly 708 is then prepared, and the valve 710 may beclosed to store the sealing components during the procedure. If thevalve 710 is a multiple port valve, a delivery line, e.g., including “Y”fitting 739 may already be connected to the valve 710, similar to theembodiment shown in FIGS. 16A and 16B. If the valve 710 is simply ashut-off valve, the vials 722 may be disconnected, and the “Y” fitting739 and/or other delivery line may be connected to the valve 710, asshown in FIG. 20D.

[0187] At any time, e.g., when it is time to deliver the sealingcomponents in the barrels 732, the plunger assembly 733 may be depressedwhile the valve 710 remains closed, causing the plungers 734 to advanceinto the barrels 732. Because the valve 710 is closed, the pistons 735are unable to move substantially, thereby causing the springs 737 tocompress, as shown in FIG. 20E. Once the plunger assembly 733 isdepressed to a desired position, the plunger assembly 733 may be lockedto prevent the springs 737 from pushing the plunger assembly 733 backout of the barrels 732. This may involve closing a latch or otherconnector (not shown). Alternatively, the plunger assembly 733 mayinclude cooperating ratchets (also not shown), e.g., on the plungers734, that may allow the plungers 734 to advance into but not retract outof the barrels 732.

[0188] With the plunger assembly 733 locked in the advanced positionshown in FIG. 20E, the springs 737 are under compression, and aretherefore biased to direct the pistons 735 distally into the barrels732. When the delivery line is established, e.g., including anintroducer sheath, delivery sheath, and the like disposed within thepuncture to be sealed (not shown), the valve 710 may be opened or movedto the delivery position such that the outlets 736 communicate with the“Y” fitting 739 and/or delivery line.

[0189] As shown in FIG. 20F, the bias of the springs 737 push thepistons 735 distally to inject the sealing components out of the barrels732 through the outlets 736. The sealing components may then mix and/orotherwise travel through the delivery line into the puncture, similar tothe embodiments described above.

[0190] One advantage of the internal spring arrangement of theembodiment of FIGS. 20A-20F is that a cover may not be needed, becausethe springs are located within the barrels. In contrast, the externalspring arrangement of FIGS. 19A-19C, because the spring 642 is outsidethe barrels 632, a cover 656 may be desired to conceal and protect thespring 642 from damage.

[0191] The foregoing detailed description includes passages that arechiefly or exclusively concerned with particular features or aspects ofparticular embodiments of the invention. It should be understood thatthis is for clarity and convenience, and that a particular feature maybe relevant in more than just the passage in which it is disclosed andembodiment in which it is described. Similarly, although the variousfigures and descriptions herein relate to specific embodiments of theinvention, it is to be understood that where a specific feature isdisclosed in the context of a particular figure or embodiment, suchfeature may also be used, to the extent appropriate, in the context ofanother figure or embodiment, in combination with another feature, or inthe invention in general.

[0192] For example, while various embodiments of retraction assemblies,auto-injector assemblies, occlusion members, and the like have beendescribed herein in exemplary combinations with one another, it will beappreciated by those skilled in the art that the described embodimentsmay be interchanged with one another without departing from the scope ofthe invention.

[0193] Further, it should be understood, that the invention is not to belimited to the particular described embodiments, but is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

[0194] It will be appreciated that many embodiments of retractionassemblies, auto-injector assemblies, occlusion members, and the likehave been described herein in exemplary combinations with one another.It will be appreciated by those skilled in the art that the variousembodiments may be interchanged with one another without deviating fromthe scope of the present invention.

[0195] While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

What is claimed:
 1. An apparatus for delivering a sealing compound intoa puncture extending through tissue, comprising: a pair of barrels, eachbarrel having a chamber for storing a component of the sealing compound,each chamber further having access port in a distal portion of thechamber; a plunger assembly comprising a pair of pistons, each pistonslidable within a respective one of the barrel chambers from a proximalposition to a distal position for delivering the components out of thebarrel chambers through the respective ports; an auto-injection assemblycoupled to the plunger assembly, the auto-injection assembly comprisinga spring mechanism locked in an inactive condition, and an actuatorcoupled to the spring mechanism, the actuator activatable to release thespring mechanism, whereupon the spring mechanism directs the pistonstowards their distal position to thereby deliver the components out ofthe barrel chambers.
 2. The apparatus of claim 1, wherein the springmechanism comprises a spring coupled to the plunger assembly and atleast one of the barrels.
 3. The apparatus of claim 2, wherein thespring comprises a compression spring compressed between a hub coupledto the barrels and a stop member coupled to the actuator, and a shaftextends from the plunger assembly adjacent the spring, and wherein thestop member comprises a passage that is aligned with the spring when theactuator is activated, whereby the spring is released to contact theshaft and direct the pistons distally into the respective barrelchambers.
 4. The apparatus of claim 1, wherein the spring mechanismcomprises one-or more springs disposed within at least one of the barrelchambers.
 5. The apparatus of claim 4, the plunger assembly furthercomprising: a handle member comprising a pair of plungers, each plungerdisposed proximate a respective one of the pistons and slidable within arespective barrel chamber, the one or more springs comprising springscoupled between the respective plungers and pistons within therespective barrel chambers.
 6. The apparatus of claim 5, wherein thesprings bias the respective pistons towards a predetermined distancefrom the plungers.
 7. The apparatus of claim 1, further comprising avalve coupled to the barrel ports, the valve configured for selectivelyplacing the respective barrel chambers in communication with an outletline and an inline line.
 8. The apparatus of claim 7, further comprisinga source of further components of the sealing compound in communicationwith the inlet line, the valve being movable to a loading position inwhich the barrel chambers are in communication with the inlet line toreceive the further sealing compound components for mixing with thesealing compound components in barrel chambers.
 9. The apparatus ofclaim 8, further comprising a “Y” fitting communicating with therespective barrel ports and the valve.
 10. The apparatus of claim 1,further comprising a delivery sheath communicating with the barrel portsfor delivering a sealing component from the barrel chambers into apuncture through tissue.
 11. A method for delivering a sealing compoundfrom a delivery device comprising a pair of barrels including outletsand a plunger assembly slidable within the barrels from a first positionto a second position for injecting components out of the barrels throughthe outlets, the method comprising: providing sealing components in thebarrels with the plunger assembly in the first position; activating anactuator coupled to a spring mechanism to release the spring mechanism,whereupon the spring mechanism directs the plunger assembly towards thesecond position to inject the sealing components out of the barrels. 12.The method of claim 11, wherein the sealing components are provided inthe barrels by: moving a valve coupled to the outlets of the barrels toa first position wherein the outlets communicate with containerscomprising sealing components therein; advancing the plunger assemblyinto the barrels to inject the sealing components in the barrels intothe containers to mix the sealing components in the barrels with thesealing components in the containers; and withdrawing the plungerassembly from the barrels to draw mixed sealing components from thecontainers into the barrels.
 13. The method of claim 12, wherein thesealing components in the barrels comprise one or more buffer solutions,and wherein the sealing components in the containers comprise solidpolymer precursor components.
 14. The method of claim 13, furthercomprising shaking the containers to dissolve the polymer precursorcomponents in the one or more buffer solutions.
 15. The method of claim11, further comprising: introducing a delivery sheath into a puncturethrough tissue; connecting the barrels to a lumen of the deliverysheath, wherein the actuator is activated after the delivery sheath isintroduced into the puncture such that the sealing components areinjected from the barrels through the lumen of the delivery sheath andinto the puncture.
 16. The method of claim 15, wherein the barrels areconnected to the delivery sheath via a “Y” fitting that mixes thesealing components in the barrels together.
 17. The method of claim 15,further comprising: introducing an occlusion member into the punctureuntil an expandable member on the occlusion member is disposed within abody lumen communicating with the puncture; expanding the expandablemember within the body lumen; and manipulating the expandable member tosubstantially seal the body lumen from the puncture before activatingthe actuator to inject the sealing components into the puncture.
 18. Themethod of claim 15, wherein a retraction assembly is coupled to thedelivery sheath and the occlusion member, and wherein the plungerassembly triggers a release of the retraction assembly as the plungerassembly slides towards the second position, whereupon the retractionassembly automatically withdraws the delivery sheath at least partiallyfrom the puncture to fill at least a portion of the puncture with thesealing components.
 19. An apparatus for sealing a puncture throughtissue, comprising: a syringe assembly comprising a plurality of barrelscomprising components of a sealing compound therein, a plunger assemblyslidable within the barrels from a proximal position to a distalposition for injecting the components out of the barrels; anauto-injector assembly comprising a spring mechanism locked in aninactive condition, and an actuator coupled to the spring mechanism thatis activatable to release the spring mechanism, whereupon the springmechanism directs the plunger assembly towards the distal position toinject the sealing components out of the barrels; a delivery sheathcomprising a proximal end, a distal end having a size and shape forinsertion into a puncture through tissue, and a lumen extendingtherebetween that communicates with the barrels for delivering thesealing components injected out of the barrels into the puncture. 20.The apparatus of claim 19, further comprising: a source of sealingcomponents; and a valve movable between a first position wherein thebarrels communicate with the source of sealing components, and a secondposition wherein the barrels communicate with the lumen of the deliverysheath.
 21. An apparatus for delivering a sealing compound into apuncture extending through tissue, comprising: a pair of barrelscomprising components of a sealing compound within interiors of thebarrels, the barrels comprising outlets communicating with therespective interiors, the outlets coupled to a valve for selectivelyopening and closing the outlets; a plunger assembly slidable within thebarrels comprising a pair of pistons slidable within respective barrels,a handle member comprising a pair of plungers disposed proximate thepistons and slidable within the barrels between proximal and distalpositions, and springs coupled between the plungers and the pistonswithin the respective barrels for biasing the pistons towards apredetermined distance from the plungers; and a latch for securing thehandle member relative to the barrels in the distal position, whereby,with the valve closed, the piston.
 22. The apparatus of claim 21,further comprising sealing components in the barrels, and wherein thehandle member may be advanced distally within the barrels with the valveclosed to compress the springs between the plungers and the pistons,whereby, when the valve is opened, the springs direct the pistonsdistally to inject the sealing components out of the barrels through theoutlets.
 23. A method for delivering a sealing compound from a deliverydevice comprising a pair of barrels including outlets and a plungerassembly slidable within the barrels and comprising a pair of pistonsslidable within respective barrels, a pair of plungers disposedproximate the pistons and slidable within the barrels between proximaland distal positions, the pistons being biased towards a predetermineddistance from the plungers, the method comprising: providing sealingcomponents in the barrels with the plungers in a proximal position withthe outlets closed; advancing the plungers into the barrels to a distalposition, thereby reducing the distance between the pistons and theplungers to less than the predetermined distance; locking the plungersin the distal position; opening the outlets, whereupon the pistonsautomatically advance distally within the barrels to return towards thepredetermined distance from the plungers, thereby injecting the sealingcomponents out of the barrels.
 24. The method of claim 23, wherein thesealing components are provided in the barrels by: opening the outletswith the outlets communicating with a container of sealing components;advancing the plunger assembly to inject one or more buffers in thebarrels into the containers to mix with the sealing components; andretracting the plunger assembly to draw mixed sealing components intothe barrels.